Drugs / Buprenorphine
Buprenorphine
also known as
BUP · Suboxone · BTDS · Sublocade · buprenorphine hydrochloride · Probuphine · Subutex · XR-B · +35 more
Regulatory milestones approvals, filings & regulatory actions · 15 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic pain syndrome 1 milestone | |||||
| Filed | EU (EMA) | Buvidal | chronic pain syndrome | 2021-11-30 | “the European Medicines Agency (EMA) has accepted the company’s submission of a Type II variation application for Buvidal® (buprenorphine) prolonged release injection to include...” camurus.com ↗ |
| Filed opiate dependence 8 milestones | |||||
| Filed | US (FDA) | BRIXADI | opiate dependence | 2022-11-23 | “The New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly injections for subcutaneous (SC) use (CIII) for moderate to severe opioid use...” braeburnrx.com ↗ “today announced the Prior Approval Supplement (PAS) for SUBLOCADE• (buprenorphine extended-release) injection submitted by lndivior, Inc. has been granted Priority Review...” indivior.com ↗ “has resubmitted to the U.S. Food and Drug Administration (FDA) its New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection” braeburnrx.com ↗ “Braeburn Inc. has resubmitted the New Drug Application (NDA) for Brixadi*” camurus.com ↗ |
| Rejected (CRL) | US (FDA) | BRIXADI | opiate dependence | 2020-12-02 | “received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its new drug application (NDA) for Brixadi™ (buprenorphine)” camurus.com ↗ “FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection” braeburnrx.com ↗ |
| Filed | US (FDA) | BRIXADI | opiate dependence | 2020-06-01 | “Braeburn announces that it has requested final approval from the U.S. Food and Drug Administration (FDA) of the New Drug Application for BRIXADI™” braeburnrx.com ↗ |
| Filed | US (FDA) | — | opiate dependence | 2018-05-28 | “Braeburn announces the resubmission of the New Drug Application (NDA) for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly depot injection for the...” braeburnrx.com ↗ “Braeburn has resubmitted the New Drug Application (NDA) for CAM2038 weekly and monthly buprenorphine depot injections to the US Food and Drug Administration (FDA)” camurus.com ↗ |
| Filed | US (FDA) | — | opiate dependence | 2017-07-20 | “Braeburn and Camurus Announce Submission of NDA for Long-Acting Buprenorphine (CAM2038) for Opioid Use Disorder” braeburnrx.com ↗ |
| Filed | Other | Probuphine | opiate dependence | 2017-06-13 | “Knight’s New Drug Submission (NDS) has been accepted for review by Health Canada for PROBUPHINE® (buprenorphine subdermal implant) for the treatment of opioid drug dependence.” knighttx.com ↗ “Knight’s New Drug Submission (NDS) has been accepted for review by Health Canada for Probuphine® (buprenorphine) implant for the treatment of opioid drug dependence.” braeburnrx.com ↗ “CAM2038 marketing authorization applications under review by healthcare authorities in the EU and Australia” camurus.com ↗ |
| Filed | US (FDA) | Zubsolv | opiate dependence | 2015-04-23 | “After the period Orexo submitted application to FDA for expanded label for Zubsolv®.” orexo.com ↗ “Orexo submitted application to FDA for expanded label for Zubsolv®.” orexo.com ↗ “FDA accepted submission of 2.9 mg Zubsolv dosage.” orexo.com ↗ |
| Filed | EU (EMA) | Zubsolv | opiate dependence | — | “Together with Mundipharma Orexo made the first EU regulatory submission of a Marketing Authorisation Application (MAA) for Zubsolv for the treatment of opioid dependence” orexo.com ↗ “CAM2038 marketing authorization applications under review by healthcare authorities in the EU” camurus.com ↗ |
| Filed opioid abuse 2 milestones | |||||
| Filed | US (FDA) | Probuphine | opioid abuse | 2015-08-31 | “announced the resubmission by Braeburn Pharmaceuticals of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Probuphine®” titanpharm.com ↗ |
| Rejected (CRL) | US (FDA) | Probuphine | opioid abuse | — | “in consultation with the FDA to address a key question in the Complete Response Letter issued in April 2013 regarding the clinical benefit of Probuphine.” titanpharm.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansion | US (FDA) | SUBLOCADE | — | 2025-02-21 | fda.gov ↗ |
| Label expansion | US (FDA) | BUTRANS | — | 2017-10-13 | fda.gov ↗ |
| Approved | EU (EMA) | Suboxone | — | 2006-09-26 | europa.eu ↗ |
| Approved | US (FDA) | BUPRENEX | — | 1981-12-29 | fda.gov ↗ |
Trials 308 · started per year
today
US approved 1981
EU approved 2006
3
2
1
3
10
3
4
4
8
5
4
3
4
4
7
12
9
11
9
13
10
10
14
19
12
5
11
7
9
9
13
8
10
9
11
7
8
12
1981198219831984198519861987198819891990199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT06726200 | Feb 2026 → Jan 2029 expected | substance-related disorder | Rachel R. Luba | Recruiting | No outcome recorded |
| Phase 0 | NCT03766893 | Sep → Dec 2018 | opiate dependence | Lifespan | Completed | No outcome recorded |
| Phase 0 | NCT03489161 | Aug 2018 | opiate dependence, substance withdrawal syndrome | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 0 | NCT01860287 | Sep 2013 → Jan 2017 | — | University of Chicago | Completed | No outcome recorded |
| Phase 144 trials · 1 met primary · 2 missed | ||||||
| Phase 1 | NCT07799571 | Oct 2026 → Oct 2031 expected | sickle cell-hemoglobin c disease syndrome | Natasha Archer | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06086275 | Jun 2024 → Oct 2025 | substance-related disorder | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 1 | NCT04122755 | Sep 2019 → May 2021 | opiate dependence | Alar Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03996694 | Jul → Oct 2019 | respiratory underresponsiveness to hypoxia and hypercapnia | BioDelivery Sciences International | Completed | Missed primary |
| Phase 1 | NCT03975010 | May 2019 → Mar 2020 | chronic pain syndrome | Mundipharma (China) Pharmaceutical Co. Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT03747341 | Mar 2018 → Jan 2019 | substance-related disorder | Indivior Inc. | Completed | Met primary |
| Phase 1 | NCT03715634 | Sep 2017 → Jun 2018 | opiate dependence | Indivior Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02666001 | Jan → Jun 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02372591 | Aug 2015 → Jun 2017 | chronic pain syndrome, opiate dependence | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT02477267 | Jun → Jul 2015 | opiate dependence | INSYS Therapeutics Inc | Completed | No outcome recorded |
| Phase 1 | NCT02431624 | Mar → May 2015 | — | Mundipharma Research Limited | Completed | No outcome recorded |
| Phase 1 | NCT02160067 | May → Aug 2014 | — | Mundipharma Research Limited | Completed | No outcome recorded |
| Phase 1 | NCT01642030 | Aug 2013 → Jul 2017 | opiate dependence | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT01311570 | Oct 2012 → Feb 2013 | depressive disorder | Shalvata Mental Health Center | Unknown | No outcome recorded |
| Phase 1 | NCT02198235 | Oct 2012 → Jan 2014 | — | Hospital for Special Surgery, New York | Completed | Missed primary |
| Phase 1 | NCT01671410 | Aug 2012 → Sep 2016 | neonatal abstinence syndrome | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 1 | NCT03002961 | Jul 2012 → Feb 2013 | opiate dependence | Indivior Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01999114 | Mar → Oct 2012 | — | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 1 | NCT01396005 | Sep → Dec 2011 | hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01366001 | Aug 2011 → Feb 2012 | cocaine abuse | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01275599 | Jan → Apr 2011 | chronic hepatitis C virus infection, opiate dependence | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT02765867 | Nov 2010 → May 2011 | substance-related disorder | Indivior Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01643759 | Jul 2009 → Mar 2010 | osteoarthritis | Mundipharma (China) Pharmaceutical Co. Ltd | Completed | No outcome recorded |
| Phase 1 | NCT00733720 | Aug → Dec 2008 | cocaine dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT00877591 | Apr 2008 → Apr 2013 | HIV infectious disease, opiate dependence | University of California, San Francisco | Completed | No outcome recorded |
| Phase 1 | NCT00469053 | May → Nov 2007 | — | Grünenthal GmbH | Terminated | No outcome recorded |
| Phase 1 | NCT00469404 | May → Nov 2007 | — | Grünenthal GmbH | Terminated | No outcome recorded |
| Phase 1 | NCT00387777 | Oct → Dec 2006 | — | Grünenthal GmbH | Terminated | No outcome recorded |
| Phase 1 | NCT00388219 | Oct → Nov 2006 | — | Grünenthal GmbH | Terminated | No outcome recorded |
| Phase 1 | NCT00347815 | Jun → Aug 2006 | — | Danish University of Pharmaceutical Sciences | Unknown | No outcome recorded |
| Phase 1 | NCT03785613 | Nov 2005 → Mar 2006 | — | Grünenthal GmbH | Completed | No outcome recorded |
| Phase 1 | NCT00886002 | Nov 2004 → Jan 2005 | — | Janssen-Cilag A.G., Switzerland | Completed | No outcome recorded |
| Phase 1 | NCT01148537 | Jul → Dec 2004 | — | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 1 | NCT03770234 | Apr → May 2004 | — | Grünenthal GmbH | Completed | No outcome recorded |
| Phase 1 | NCT00521248 | Apr 2004 → Jan 2010 | neonatal abstinence syndrome | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 1 | NCT01259115 | Oct 2002 → Jun 2003 | — | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 1 | NCT00015041 | Nov 1996 → Jun 1998 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT00015288 | Nov 1996 → ? | heroin dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT00000355 | Nov 1994 → Jan 1996 | opiate dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT00000224 | Feb 1993 → ? | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT00000222 | Jul 1992 → ? | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT00000221 | Apr 1992 → ? | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT00000219 | Dec 1991 → Jul 2001 | substance-related disorder | University of Vermont | Completed | No outcome recorded |
| Phase 1 | NCT00000220 | Jun 1991 → Jul 2001 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1/213 trials | ||||||
| Phase 1/2 | NCT07430345 | May → Dec 2026 expected | — | The Cooper Health System | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06442566 | Aug 2024 → Mar 2028 expected | chronic pain syndrome, substance withdrawal syndrome | Medical University of South Carolina | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03861338 | Mar 2019 → Feb 2020 | opiate dependence | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT03580902 | Jan 2019 → Nov 2021 | opiate dependence | CBT4CBT, LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT03608696 | Aug 2018 → Jul 2019 | neonatal abstinence syndrome | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 1/2 | NCT02181231 | Jun 2016 → Apr 2018 | major depressive disorder | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1/2 | NCT02360007 | Jan 2015 → Jun 2016 | opiate dependence | University of Vermont Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02263248 | Dec 2014 → Jan 2017 | major depressive disorder | Centre for Addiction and Mental Health | Completed | No outcome recorded |
| Phase 1/2 | NCT02249026 | Oct 2014 → Jun 2016 | neonatal abstinence syndrome, toxic or drug-related embryofetopathy | Gauda, Estelle B., M.D. | Unknown | No outcome recorded |
| Phase 1/2 | NCT01136356 | Jul 2010 → Mar 2012 | opiate dependence, opioid abuse | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1/2 | NCT00947466 | Feb 2010 → Nov 2012 | chemotherapy-induced oral mucositis | Mundipharma Research Limited | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00634803 | Sep 2009 → May 2015 | chronic pain syndrome, opiate dependence | Yale University | Completed | No outcome recorded |
| Phase 1/2 | NCT00367302 | Aug 2006 → Jan 2008 | opiate dependence | National Development and Research Institutes, Inc. | Completed | No outcome recorded |
| Phase 277 trials · 7 met primary · 2 missed | ||||||
| Phase 2 | NCT05339256 | Jun → Dec 2026 | substance-related disorder | New York State Psychiatric Institute | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06441604 | Oct 2025 → Jun 2026 overdue | substance-related disorder | Brigham and Women's Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04737603 | Jul 2025 | opiate dependence | University of California, Davis | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06379984 | May 2025 → Dec 2026 expected | substance-related disorder | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 2 | NCT05778591 | May 2024 → Dec 2026 expected | schizophrenia | University of California, Los Angeles | Recruiting | No outcome recorded |
| Phase 2 | NCT05262270 | Apr 2023 → Jun 2025 | substance-related disorder | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT05283304 | Mar → Oct 2023 | methamphetamine dependence | Madhukar H. Trivedi, MD | Terminated | No outcome recorded |
| Phase 2 | NCT04480554 | Jan 2023 → Jun 2025 | HIV infectious disease, opiate dependence | University of Pennsylvania | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04454411 | Aug 2022 → Aug 2024 | opiate dependence | University of Pennsylvania | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03744663 | Jun → Dec 2022 | substance-related disorder | Wake Forest University Health Sciences | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT05991622 | Apr 2022 → Aug 2025 | HIV infectious disease, opiate dependence | Rhode Island Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04752384 | Jul 2021 → Apr 2024 | head and neck squamous cell carcinoma | Medical College of Wisconsin | Completed | No outcome recorded |
| Phase 2 | NCT04464980 | Jun 2021 → Dec 2026 expected | substance-related disorder | NYU Langone Health | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04571619 | Jan 2021 → Dec 2023 | chronic pain syndrome, end stage renal failure, opiate dependence | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | Met primary |
| Phase 2 | NCT04352166 | Dec 2020 → Jun 2025 | opiate dependence | Frances R Levin | Suspended | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03492099 | Aug 2018 → Sep 2019 | sickle cell disease | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT03420313 | Mar 2018 → Jul 2021 | opiate dependence | University of Vermont | Unknown | Met primary |
| Phase 2 | NCT03256487 | Sep 2017 → Feb 2018 | — | Alameda Health System | Unknown | No outcome recorded |
| Phase 2 | NCT03156907 | Sep 2017 → Dec 2024 | — | University Hospital, Clermont-Ferrand | Unknown | Met primary |
| Phase 2 | NCT03254459 | Sep → Nov 2017 | — | INSYS Therapeutics Inc | Completed | No outcome recorded |
| Phase 2 | NCT02611752 | Oct 2015 → Apr 2016 | opiate dependence | Braeburn Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT02176291 | Aug 2014 → Apr 2017 | major depressive disorder | Jordan F. Karp | Completed | No outcome recorded |
| Phase 2 | NCT02044094 | Nov 2013 → Jul 2014 | substance-related disorder | Indivior Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01871285 | Jun 2013 → Jul 2014 | — | BioDelivery Sciences International | Completed | Missed primary |
| Phase 2 | NCT01708707 | Dec 2012 → Oct 2017 | neonatal abstinence syndrome | Pediatrix | Completed | No outcome recorded |
| Phase 2 | NCT01666119 | Aug 2012 → Jan 2013 | opiate dependence | BioDelivery Sciences International | Completed | No outcome recorded |
| Phase 2 | NCT01582347 | Mar → Nov 2012 | opiate dependence | Indivior Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01500200 | Dec 2011 → Mar 2013 | major depressive disorder | Alkermes, Inc. | Completed | Met primary |
| Phase 2 | NCT01071538 | May 2010 → May 2012 | depressive disorder | University of Pittsburgh | Completed | No outcome recorded |
| Phase 2 | NCT00941304 | Aug → Nov 2009 | dental pulp disorder | BioDelivery Sciences International | Completed | Missed primary |
| Phase 2 | NCT00612287 | Apr → May 2009 | chronic pain syndrome | National Institute on Drug Abuse (NIDA) | Unknown | No outcome recorded |
| Phase 2 | NCT00637000 | Mar → Sep 2008 | opiate dependence | Indivior Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00640835 | Feb → Oct 2008 | opiate dependence | Indivior Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00460239 | Jan 2007 → Jul 2009 | substance-related disorder | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT00403234 | Nov 2006 → Apr 2007 | — | Purdue Pharma LP | Terminated | No outcome recorded |
| Phase 2 | NCT00719095 | Apr 2006 → Mar 2010 | opiate dependence | University of Vermont Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT01967641 | Nov 2005 → Jun 2011 | opiate dependence | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 2 | NCT01075971 | Sep → Nov 2005 | opiate dependence | Indivior Inc. | Completed | Met primary |
| Phase 2 | NCT00182572 | Jul 2005 → ? | opiate dependence | National Development and Research Institutes, Inc. | Unknown | Met primary |
| Phase 2 | NCT00398008 | Oct 2004 → Dec 2006 | HIV infectious disease, opiate dependence | Yale University | Withdrawn | No outcome recorded |
| Phase 2 | NCT00149539 | Jun 2004 → Jan 2006 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT00218101 | May 2004 → Mar 2005 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00383045 | Apr 2003 → Aug 2007 | opiate dependence | Yale University | Completed | Mixed |
| Phase 2 | NCT00000334 | Dec 2002 → Nov 2004 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000331 | Dec 2002 | heroin dependence | University of Colorado, Denver | Withdrawn | No outcome recorded |
| Phase 2 | NCT00000240 | Apr 1999 → ? | substance-related disorder | University of Vermont | Completed | No outcome recorded |
| Phase 2 | NCT00000328 | Jul → Aug 1997 | heroin dependence | University of Colorado, Denver | Withdrawn | No outcome recorded |
| Phase 2 | NCT00000237 | May 1997 → ? | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00315835 | Oct 1996 → Nov 1997 | — | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 2 | NCT00000341 | Aug 1996 → Aug 2000 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000319 | Jun 1996 → Jan 2005 | opiate dependence | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT00344812 | Jan 1996 → Jun 1998 | opiate dependence | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT00000298 | Aug 1995 → ? | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000273 | Aug 1995 → Nov 2005 | heroin dependence | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 2 | NCT00000230 | Jan 1995 → ? | substance-related disorder | University of Vermont | Completed | No outcome recorded |
| Phase 2 | NCT00000318 | Dec 1994 → Mar 2004 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000226 | Nov 1994 → ? | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000227 | Aug 1994 → ? | substance-related disorder | University of Vermont | Completed | No outcome recorded |
| Phase 2 | NCT00000223 | Jun 1993 → ? | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000233 | May 1993 → ? | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000225 | Dec 1992 → ? | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000209 | Nov 1992 → ? | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000357 | Jun 1992 → Aug 1993 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000232 | Mar 1992 → ? | substance-related disorder | University of Vermont | Completed | No outcome recorded |
| Phase 2 | NCT00000231 | Feb 1992 → ? | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000208 | Feb 1992 → ? | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000214 | Jan 1992 → Jan 1993 | cocaine abuse | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 2 | NCT00000206 | Apr 1991 → Aug 2005 | substance-related disorder | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 2 | NCT00000210 | Sep 1989 → Feb 1996 | cocaine dependence, heroin dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000211 | Sep 1989 → Feb 1996 | cocaine abuse, heroin dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000202 | Aug 1988 → May 2006 | substance-related disorder | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT00000204 | Aug 1988 → May 2006 | substance-related disorder | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT00000203 | Aug 1988 → May 2006 | substance-related disorder | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT00000239 | — | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000234 | — | opiate dependence | University of Vermont | Completed | No outcome recorded |
| Phase 2 | NCT00000236 | — | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000235 | — | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2/38 trials · 1 missed | ||||||
| Phase 2/3 | NCT06316830 | Jan 2025 → Aug 2027 expected | substance-related disorder | Rhode Island Hospital | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05011266 | Apr 2023 → Jan 2027 expected | opiate dependence | New York State Psychiatric Institute | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04991974 | Sep 2021 → Jan 2026 | opiate dependence | Friends Research Institute, Inc. | Completed | No outcome recorded |
| Phase 2/3 | NCT04408313 | Oct 2020 → May 2026 overdue | opiate dependence | Friends Research Institute, Inc. | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT03113409 | Jun 2017 → Dec 2020 | opiate dependence | New York State Psychiatric Institute | Terminated | No outcome recorded Stop: Business |
| Phase 2/3 | NCT01561079 | Feb 2012 → Jun 2016 | neonatal abstinence syndrome | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2/3 | NCT01402492 | Sep 2011 → Jan 2013 | cocaine dependence | University of California, Los Angeles | Completed | Missed primary |
| Phase 2/3 | NCT01082679 | Jun 2009 → Mar 2011 | opiate dependence | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 377 trials · 16 met primary · 5 missed | ||||||
| Phase 3 | NCT06306443 | Jun 2025 → Jan 2029 expected | substance-related disorder | Friends Research Institute, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT07524738 | Jun 2025 → Jul 2026 overdue | substance-related disorder | Friends Research Institute, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06494904 | Dec 2024 → Sep 2027 expected | substance-related disorder | Yale University | Recruiting | No outcome recorded |
| Phase 3 | NCT06023459 | Oct 2024 → Nov 2025 | substance-related disorder | Yih-Ing Hser | Completed | No outcome recorded |
| Phase 3 | NCT05790252 | Nov 2023 → Aug 2026 | pregnancy disorder, substance-related disorder | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 3 | NCT05589181 | Apr 2023 → Sep 2026 overdue | substance-related disorder | Rutgers, The State University of New Jersey | Recruiting | No outcome recorded |
| Phase 3 | NCT05427981 | Oct 2022 → Jan 2024 | major depressive disorder | New York State Psychiatric Institute | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03616236 | Jul 2022 → Aug 2026 | substance-related disorder | Friends Research Institute, Inc. | Suspended | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03646058 | Oct 2021 → Oct 2026 expected | major depressive disorder | Nîmes University Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT04523792 | Jan → Dec 2021 | opiate dependence | Virginia Commonwealth University | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT04455802 | Oct 2020 → May 2021 | neonatal abstinence syndrome | Women and Infants Hospital of Rhode Island | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT03678792 | Nov 2019 → Sep 2020 | opiate dependence, substance withdrawal syndrome | University of Alabama at Birmingham | Withdrawn | No outcome recorded |
| Phase 3 | NCT05164549 | Aug 2019 → Apr 2022 | — | King's College London | Completed | Met primary |
| Phase 3 | NCT03967327 | Apr 2019 → Dec 2020 | — | Mundipharma (China) Pharmaceutical Co. Ltd | Unknown | No outcome recorded |
| Phase 3 | NCT03818399 | Jan 2019 → Feb 2021 | substance-related disorder | Virginia Commonwealth University | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03711318 | Nov 2018 → Dec 2021 | heroin dependence | New York State Psychiatric Institute | Terminated | No outcome recorded |
| Phase 3 | NCT03610048 | Aug 2018 → May 2020 | major depressive disorder | Alkermes, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03232346 | Aug 2017 → Jun 2021 | opiate dependence | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 3 | NCT03188185 | Jun 2017 → Feb 2020 | major depressive disorder | Alkermes, Inc. | Completed | Missed primary |
| Phase 3 | NCT02891798 | Oct 2016 → Jul 2021 | — | Brian Williams | Completed | Met primary |
| Phase 3 | NCT02946073 | Sep 2016 → May 2018 | chronic pain syndrome | Braeburn Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02696096 | Aug 2016 → Feb 2020 | opiate dependence | Butler Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02634788 | Jan → Jun 2016 | — | INSYS Therapeutics Inc | Completed | Met primary |
| Phase 3 | NCT02651584 | Dec 2015 → Oct 2016 | opiate dependence | Braeburn Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02672111 | Nov 2015 → May 2017 | substance-related disorder | Braeburn Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02537574 | Aug 2015 → Oct 2016 | substance-related disorder | Alkermes, Inc. | Completed | Missed primary |
| Phase 3 | NCT02187198 | Mar 2015 → Feb 2022 | opiate dependence | Yale University | Completed | No outcome recorded |
| Phase 3 | NCT02310581 | Feb → Mar 2015 | — | INSYS Therapeutics Inc | Terminated | Met primary Stop: Business |
| Phase 3 | NCT01755546 | Dec 2012 → Oct 2014 | neuropathy, painful, osteoarthritis | BioDelivery Sciences International | Completed | No outcome recorded |
| Phase 3 | NCT01675167 | Sep 2012 → Jun 2014 | — | BioDelivery Sciences International | Completed | Met primary |
| Phase 3 | NCT01633944 | Aug 2012 → Dec 2013 | — | BioDelivery Sciences International | Completed | Met primary |
| Phase 3 | NCT01431742 | Jul 2012 → Jul 2013 | — | BioDelivery Sciences International | Withdrawn | No outcome recorded |
| Phase 3 | NCT01324544 | Nov 2011 → Aug 2014 | — | Purdue Pharma LP | Withdrawn | No outcome recorded |
| Phase 3 | NCT01452789 | Nov 2011 → Jun 2016 | neonatal abstinence syndrome | Thomas Jefferson University | Completed | Met primary |
| Phase 3 | NCT01407575 | Sep 2011 → Aug 2013 | major depressive disorder | University of Pittsburgh | Completed | No outcome recorded |
| Phase 3 | NCT01324570 | Jul 2011 → May 2016 | — | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 3 | NCT01298765 | Mar 2011 → Aug 2012 | neuropathy, painful, osteoarthritis | BioDelivery Sciences International | Completed | No outcome recorded |
| Phase 3 | NCT01262261 | Nov 2010 → Nov 2011 | opiate dependence | Titan Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01256450 | Nov 2010 → Jul 2011 | — | BioDelivery Sciences International | Completed | Missed primary |
| Phase 3 | NCT01114308 | Apr 2010 → May 2011 | opiate dependence | Titan Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01760473 | May 2009 → Dec 2014 | heroin dependence | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 3 | NCT00772785 | Sep 2008 → Feb 2009 | opiate dependence | Titan Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00574067 | Sep 2008 → Mar 2013 | heroin dependence | Friends Research Institute, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00768482 | Sep → Dec 2008 | opiate dependence | Titan Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00630201 | Oct 2007 → Feb 2009 | opiate dependence | Titan Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00710385 | Sep 2007 → Aug 2008 | substance-related disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 3 | NCT00531427 | Sep 2007 → Apr 2009 | chronic pain syndrome, osteoarthritis, knee | Purdue Pharma LP | Completed | Missed primary |
| Phase 3 | NCT00490919 | Jun 2007 → Jul 2008 | — | Purdue Pharma LP | Completed | Met primary |
| Phase 3 | NCT00346047 | May 2006 → Jul 2007 | — | Mundipharma K.K. | Completed | No outcome recorded |
| Phase 3 | NCT00345787 | May 2006 → Aug 2007 | osteoarthritis | Mundipharma K.K. | Completed | No outcome recorded |
| Phase 3 | NCT00271219 | Jul 2005 → Aug 2009 | opiate dependence, pregnancy disorder | Johns Hopkins University | Completed | Mixed |
| Phase 3 | NCT01125917 | Jun 2004 → Sep 2005 | — | Purdue Pharma LP | Terminated | No outcome recorded |
| Phase 3 | NCT01135524 | Apr 2004 → Aug 2005 | osteoarthritis | Purdue Pharma LP | Terminated | No outcome recorded |
| Phase 3 | NCT00312221 | Apr 2004 → Jul 2005 | osteoarthritis | Purdue Pharma LP | Terminated | Missed primary |
| Phase 3 | NCT00313014 | Feb 2004 → Sep 2005 | — | Purdue Pharma LP | Terminated | Met primary |
| Phase 3 | NCT00320801 | Jan 2004 → Mar 2005 | osteoarthritis | Purdue Pharma LP | Terminated | No outcome recorded |
| Phase 3 | NCT00315458 | Dec 2003 → Mar 2005 | osteoarthritis | Purdue Pharma LP | Terminated | No outcome recorded |
| Phase 3 | NCT00312572 | Jun 2003 → Jul 2004 | osteoarthritis | Purdue Pharma LP | Completed | Met primary |
| Phase 3 | NCT00078117 | Jun 2003 → May 2005 | opiate dependence | University of California, Los Angeles | Completed | Met primary |
| Phase 3 | NCT00313846 | Apr 2003 → Jun 2004 | osteoarthritis | Purdue Pharma LP | Completed | Met primary |
| Phase 3 | NCT01141283 | Apr 2003 → Jul 2004 | osteoarthritis | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 3 | NCT01151098 | Apr 2001 → Feb 2002 | chronic pain syndrome | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 3 | NCT00312195 | Mar → Jul 2001 | chronic pain syndrome | Purdue Pharma LP | Completed | Met primary |
| Phase 3 | NCT00032955 | Feb 2001 → Aug 2002 | heroin dependence, morphine dependence, substance withdrawal syndrome | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 3 | NCT00032968 | Jan 2001 → Aug 2002 | heroin dependence, morphine dependence, substance withdrawal syndrome | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 3 | NCT00313833 | Dec 2000 → Nov 2001 | chronic pain syndrome | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 3 | NCT00314652 | Jun → Oct 1999 | osteoarthritis | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 3 | NCT00315887 | Apr → Oct 1999 | chronic pain syndrome | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 3 | NCT00315445 | Dec 1997 → May 1998 | — | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 3 | NCT00315874 | Apr 1997 → Jan 1998 | — | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 3 | NCT00315848 | Nov 1996 → Dec 1999 | osteoarthritis | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 3 | NCT00000311 | Feb 1995 → Feb 1999 | substance-related disorder | Yale University | Completed | No outcome recorded |
| Phase 3 | NCT00000207 | May 1992 → Apr 1997 | substance-related disorder | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 3 | NCT00000205 | Oct 1990 → Mar 1993 | substance-related disorder | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 3 | NCT00000302 | — | heroin dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 3 | NCT01713803 | ? → May 2017 | opiate dependence | BioDelivery Sciences International | Withdrawn | No outcome recorded |
| Phase 3 | NCT00000216 | ? → Jan 2005 | cocaine abuse, opiate dependence | Yale University | Completed | No outcome recorded |
| Phase 465 trials · 2 met primary · 4 missed | ||||||
| Phase 4 | NCT07176351 | Sep 2026 → Feb 2027 expected | substance-related disorder | Yale University | Recruiting | No outcome recorded |
| Phase 4 | NCT07786012 | Sep 2026 → Aug 2028 expected | — | Icahn School of Medicine at Mount Sinai | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07485335 | Sep 2026 → Sep 2030 expected | acute opioid poisoning, substance-related disorder | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 4 | NCT07435077 | Aug → Dec 2026 expected | substance-related disorder | Wake Forest University Health Sciences | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06854029 | Jul 2026 → Dec 2029 expected | HIV infectious disease, opiate dependence | Duke University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07469501 | Jun 2026 → May 2027 expected | substance-related disorder | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07439549 | Apr → Sep 2026 overdue | opiate dependence | Pouya Azar | Recruiting | No outcome recorded |
| Phase 4 | NCT07434427 | Mar 2026 → May 2027 expected | chronic pain syndrome | Medical University of Silesia | Recruiting | No outcome recorded |
| Phase 4 | NCT06949826 | Apr 2025 → Mar 2027 expected | opiate dependence | Jenna-Leigh Wilson | Recruiting | No outcome recorded |
| Phase 4 | NCT06367387 | May 2024 → Feb 2026 overdue | chronic pain syndrome, substance-related disorder | Erin Winstanley | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06133114 | Mar 2024 → Oct 2026 expected | — | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 4 | NCT05481112 | Nov 2023 → Nov 2025 | opiate dependence | NYU Langone Health | Withdrawn | No outcome recorded |
| Phase 4 | NCT05988710 | Oct 2023 → Jan 2028 expected | opioid abuse, pain agnosia | Vanderbilt University Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05704543 | Mar → Nov 2023 | substance-related disorder | Indivior Inc. | Completed | No outcome recorded |
| Phase 4 | NCT05824832 | Feb 2023 → Jun 2026 overdue | neuropathy, painful | Loyola University | Recruiting | No outcome recorded |
| Phase 4 | NCT05118204 | Sep 2022 → Oct 2024 | chronic pain syndrome, opiate dependence | Montefiore Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05910190 | Aug 2022 → Oct 2024 | — | Fox Chase Cancer Center | Unknown | No outcome recorded |
| Phase 4 | NCT04981678 | Jan 2022 → Sep 2023 | opiate dependence | MaineHealth | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05042648 | Dec 2021 → Dec 2023 | — | Security Forces Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04995029 | Oct 2021 → Jun 2024 | opiate dependence | Indivior Inc. | Completed | No outcome recorded |
| Phase 4 | NCT04811014 | Apr 2021 → Aug 2030 expected | acute opioid poisoning, opiate dependence | The University of Texas Health Science Center, Houston | Recruiting | No outcome recorded |
| Phase 4 | NCT04219540 | Jan 2021 → Aug 2024 | opiate dependence | NYU Langone Health | Completed | No outcome recorded |
| Phase 4 | NCT04375033 | Nov 2020 → Sep 2028 expected | substance-related disorder | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 4 | NCT04276259 | Oct 2020 → Jan 2026 | major depressive disorder | Marta Peciña, MD PhD | Completed | No outcome recorded |
| Phase 4 | NCT04254081 | May 2020 → May 2021 | — | University of California, San Diego | Completed | No outcome recorded |
| Phase 4 | NCT04088266 | Jan → Dec 2020 | — | Teva Pharmaceuticals USA | Withdrawn | No outcome recorded |
| Phase 4 | NCT04060654 | Oct 2019 → May 2020 | opiate dependence | Indivior Inc. | Completed | No outcome recorded |
| Phase 4 | NCT03993392 | Aug → Dec 2019 | opiate dependence | Indivior Inc. | Completed | No outcome recorded |
| Phase 4 | NCT03908437 | Jul 2019 → Mar 2022 | opiate dependence, poisoning | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT03604159 | Jun 2019 → May 2020 | opiate dependence | NYU Langone Health | Completed | No outcome recorded |
| Phase 4 | NCT03396276 | Apr 2018 → Aug 2030 expected | substance-related disorder | The University of Texas Health Science Center, Houston | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT02416804 | Jan 2015 → Jul 2016 | spinal stenosis | Seoul National University Hospital | Completed | Met primary |
| Phase 4 | NCT02138357 | Apr 2014 → Dec 2016 | restless legs syndrome | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT01875848 | Dec 2013 → Jun 2015 | — | VA Office of Research and Development | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03117140 | Dec 2013 → Mar 2017 | — | Melinda Seering | Completed | No outcome recorded |
| Phase 4 | NCT02038790 | Nov 2013 | opiate dependence | Indivior Inc. | Completed | Missed primary |
| Phase 4 | NCT01983111 | Oct 2013 → Nov 2014 | — | Mundipharma Korea Ltd | Completed | No outcome recorded |
| Phase 4 | NCT02519387 | Jul 2013 → Jan 2015 | osteoarthritis, rheumatoid arthritis | Mundipharma Pharmaceuticals Sdn. Bhd. | Completed | No outcome recorded |
| Phase 4 | NCT01961271 | Jun 2013 → Jan 2015 | myopathy, osteoarthritis, rheumatoid arthritis | Mundipharma Pte Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT03174067 | Mar 2013 → Apr 2016 | opiate dependence, substance withdrawal syndrome | St. Joseph's Health Centre Toronto | Completed | No outcome recorded |
| Phase 4 | NCT01733693 | Jan 2013 → Jun 2017 | HIV infectious disease, opiate dependence | Albert Einstein College of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT01818700 | Sep 2012 → Jun 2013 | spinal cord disorder | Mundipharma Korea Ltd | Completed | No outcome recorded |
| Phase 4 | NCT01846455 | Sep 2012 → Apr 2013 | chronic hepatitis C virus infection, liver failure | Indivior Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02575664 | Aug 2012 → Oct 2015 | osteoarthritis | Kuopio University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01559454 | Feb 2012 → May 2014 | — | State University of New York at Buffalo | Completed | Missed primary |
| Phase 4 | NCT01809106 | Apr 2011 → Oct 2014 | cancer | Mario Negri Institute for Pharmacological Research | Completed | Missed primary |
| Phase 4 | NCT01276431 | Mar 2011 → Aug 2012 | osteoarthritis | Mundipharma Oy | Completed | No outcome recorded |
| Phase 4 | NCT01546701 | Mar 2011 → Apr 2012 | urinary tract obstruction | Tehran University of Medical Sciences | Completed | No outcome recorded |
| Phase 4 | NCT00949299 | Jan 2010 → Dec 2011 | — | University of Zurich | Terminated | No outcome recorded |
| Phase 4 | NCT00964808 | Sep 2009 → May 2013 | neuropathy, painful | Vejle Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00955162 | Aug 2009 → May 2010 | opiate dependence | Indivior Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00879996 | Apr 2009 → Oct 2011 | opiate dependence | State University of New York at Buffalo | Completed | Missed primary |
| Phase 4 | NCT00901875 | Mar → Nov 2009 | opiate dependence | Indivior Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00750217 | Aug 2008 → Feb 2009 | heroin dependence | Psychiatric University Hospital, Zurich | Unknown | No outcome recorded |
| Phase 4 | NCT00763958 | May 2008 → Sep 2009 | HIV infectious disease, opiate dependence | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 4 | NCT01019265 | Mar 2008 → Mar 2009 | osteoarthritis | Mundipharma Korea Ltd | Completed | No outcome recorded |
| Phase 4 | NCT00604188 | Feb 2008 → Dec 2009 | opiate dependence | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT00426647 | Feb 2007 → Jul 2009 | osteoarthritis | Norpharma A/S | Completed | No outcome recorded |
| Phase 4 | NCT00315341 | Apr 2006 → Aug 2010 | opiate dependence | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 4 | NCT00324038 | Mar 2006 → Dec 2007 | osteoarthritis | Napp Pharmaceuticals Limited | Completed | Met primary |
| Phase 4 | NCT00279565 | Aug 2005 → Feb 2007 | chronic hepatitis C virus infection | Indivior Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT00124358 | Aug 2005 → Dec 2008 | AIDS, opiate dependence | The New York Academy of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT00310934 | Aug 2005 → Mar 2006 | heroin dependence | Karolinska University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00367874 | Feb → Nov 2003 | opiate dependence, substance withdrawal syndrome | Sorlandet Hospital HF | Completed | No outcome recorded |
| Phase 4 | NCT00007527 | Aug 1999 → Jan 2002 | opiate dependence | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase not applicable20 trials · 1 met primary · 1 missed | ||||||
| — | NCT06772324 | Jan 2025 → Aug 2026 overdue | autism spectrum disorder | Peking University Sixth Hospital | Not yet recruiting | No outcome recorded |
| — | NCT05871424 | Jun 2023 → Feb 2024 | gallbladder disorder | Gangnam Severance Hospital | Completed | No outcome recorded |
| — | NCT05108935 | Feb 2022 → Mar 2023 | HIV infectious disease, hepatitis C virus infection, opiate dependence | Duke University | Completed | No outcome recorded |
| — | NCT05003765 | Aug 2020 → May 2022 | — | Wayne State University | Unknown | No outcome recorded |
| — | NCT03098407 | Apr 2017 → Oct 2019 | opiate dependence, pregnancy disorder | University of Pittsburgh | Completed | No outcome recorded |
| — | NCT02737826 | May 2016 → Dec 2019 | chronic pain syndrome | Medical University of South Carolina | Completed | No outcome recorded |
| — | NCT01583179 | Apr 2012 → Mar 2014 | — | University of Wisconsin, Madison | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01648270 | Apr 2012 → Dec 2016 | — | Washington University School of Medicine | Completed | No outcome recorded |
| — | NCT01296334 | Feb → Sep 2011 | — | mads u werner | Completed | Missed primary |
| — | NCT01277159 | Oct 2010 → Dec 2011 | — | Hospital for Special Surgery, New York | Completed | No outcome recorded |
| — | NCT01576575 | Jun 2010 → Mar 2014 | — | Washington University School of Medicine | Completed | No outcome recorded |
| — | NCT00913770 | Sep 2008 → Aug 2013 | opiate dependence | Yale University | Completed | Met primary |
| — | NCT00679458 | Sep 2008 → Nov 2009 | — | University of California, Los Angeles | Completed | No outcome recorded |
| — | NCT00571961 | Jan 2007 → Aug 2008 | HIV infectious disease | Yale University | Completed | No outcome recorded |
| — | NCT00486330 | May 2006 → May 2007 | HIV infectious disease | Yale University | Completed | No outcome recorded |
| — | NCT00000243 | Sep 2002 → Jan 2004 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Terminated | No outcome recorded |
| — | NCT00134888 | Dec 2000 → Nov 2002 | opiate dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| — | NCT00134875 | Dec 2000 → Dec 2002 | substance-related disorder | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| — | NCT00158236 | Jan 1997 → Mar 1998 | opioid abuse | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| — | NCT00134914 | Aug 1996 → Apr 1998 | opiate dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Comparator or background therapy89 trials | ||||||
| Phase 0 | NCT05852093 Comparator | Jun 2023 → Jun 2026 overdue | rotator cuff syndrome | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07169409 Background | Jun 2025 → Aug 2027 expected | substance-related disorder | Boulder Care | Recruiting | No outcome recorded |
| Phase 1 | NCT06406400 Background | May → Jul 2024 | opiate dependence | AstraZeneca | Terminated | No outcome recorded |
| Phase 1 | NCT04976855 Background | Aug 2022 → Jul 2023 | opiate dependence | Indivior Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04447287 Background | Jun → Nov 2020 | substance-related disorder | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03268278 Comparator | Apr 2017 → Jul 2018 | — | University Hospitals Cleveland Medical Center | Terminated | No outcome recorded |
| Phase 1 | NCT02559973 Background | Sep 2015 → Feb 2016 | substance-related disorder | Indivior Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02413281 Comparator | Mar → Sep 2015 | — | Alkermes, Inc. | Completed | Met primary |
| Phase 1 | NCT02045693 Comparator | Feb → Apr 2014 | hepatitis C virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT01723527 Background | Dec 2012 → May 2014 | HIV infectious disease, cocaine abuse, heroin dependence | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT01560221 Background | Oct 2012 → Dec 2014 | substance-related disorder | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT01377610 Comparator | Jun 2011 → Dec 2017 | opiate dependence | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 1 | NCT01046539 Comparator | Jan → Mar 2010 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT00726960 Comparator | Jan 2008 → Dec 2009 | heroin dependence, opioid abuse | Karolinska University Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT01157169 Comparator | Aug → Sep 2007 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1/2 | NCT04818086 Comparator | May 2021 → Apr 2023 | substance-related disorder | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 1/2 | NCT01188421 Comparator | Oct 2010 → Jun 2015 | opiate dependence | Johns Hopkins University | Completed | Missed primary |
| Phase 1/2 | NCT00000320 Comparator | Oct 1997 → Aug 1999 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT07420283 Background | Feb 2026 → Mar 2028 expected | substance-related disorder | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 2 | NCT06576843 Background | Sep 2024 → Jan 2026 | opiate dependence | Indivior Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04850664 Background | Mar 2021 → Nov 2022 | opiate dependence, substance withdrawal syndrome | Evon Medics LLC | Unknown | No outcome recorded |
| Phase 2 | NCT04677114 Background | Mar 2021 → Mar 2025 | opiate dependence, substance abuse | Laura Fanucchi | Completed | No outcome recorded |
| Phase 2 | NCT04225598 Comparator | Jul 2020 → Dec 2024 | opiate dependence | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT03852628 Comparator | May 2019 → May 2022 | alcohol abuse, post-traumatic stress disorder | Pharmacotherapies for Alcohol and Substance Use Disorders Alliance | Terminated | No outcome recorded |
| Phase 2 | NCT03150173 Background | Jan 2019 → Oct 2023 | opiate dependence | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03605342 Comparator | Oct 2018 → Apr 2023 | opiate dependence, post-traumatic stress disorder | VA Office of Research and Development | Terminated | No outcome recorded |
| Phase 2 | NCT01738503 Background | Oct 2012 → May 2014 | opiate dependence | Indivior Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01262092 Comparator | Oct 2010 → Dec 2011 | opiate dependence, substance withdrawal syndrome | University of Arkansas | Completed | No outcome recorded |
| Phase 2 | NCT00000299 Background | Oct 2008 → Nov 2009 | substance-related disorder | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 2 | NCT00023283 Background | Aug 2000 → Dec 2003 | heroin dependence, substance abuse | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT00000238 Background | Aug 1997 → ? | opiate dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000229 Background | Oct 1995 → ? | substance-related disorder | University of Vermont | Completed | No outcome recorded |
| Phase 2 | NCT00000228 Background | Aug 1994 → ? | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2/3 | NCT04345718 Comparator | Aug 2021 → Aug 2025 | opiate dependence | Gavin Bart | Completed | No outcome recorded |
| Phase 2/3 | NCT04893525 Comparator | Jul 2021 → Dec 2027 expected | substance-related disorder | University of British Columbia | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03380533 Comparator | Sep 2016 → Dec 2017 | rotator cuff syndrome | Hospital Italiano de Buenos Aires | Completed | No outcome recorded |
| Phase 2/3 | NCT02543944 Comparator | Feb 2016 → May 2021 | drug dependence | University of Arkansas | Completed | No outcome recorded |
| Phase 2/3 | NCT02617199 Comparator | Nov 2015 → Dec 2016 | acute pancreatitis | Hospital General Naval de Alta Especialidad - Escuela Medico Naval | Unknown | No outcome recorded |
| Phase 2/3 | NCT01021696 Comparator | Nov 2009 → Jul 2010 | dementia | University of Bergen | Completed | No outcome recorded |
| Phase 2/3 | NCT00684554 Comparator | Dec 2007 → Aug 2008 | heroin dependence | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 3 | NCT07296770 Background | Oct 2026 → Dec 2028 expected | chronic pain syndrome | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04116528 Comparator | Aug 2020 → Apr 2025 | major depressive disorder | Stanford University | Completed | No outcome recorded |
| Phase 3 | NCT03918850 Comparator | Jul 2020 → Jan 2025 | drug dependence, neonatal abstinence syndrome, pregnancy disorder, substance abuse +1 | T. John Winhusen, PhD | Completed | No outcome recorded |
| Phase 3 | NCT02526212 Background | Jan 2017 → May 2019 | opioid abuse | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT02696434 Background | Apr 2016 → Nov 2017 | substance-related disorder | Alkermes, Inc. | Completed | Missed primary |
| Phase 3 | NCT02510014 Background | Jul 2015 → Jan 2017 | substance-related disorder | Indivior Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02357901 Background | Jan 2015 → Apr 2016 | opiate dependence | Indivior Inc. | Completed | Met primary |
| Phase 3 | NCT02180659 Comparator | Jul 2014 → May 2015 | opiate dependence | Titan Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01908842 Comparator | Aug 2013 → Apr 2014 | opiate dependence | Orexo AB | Completed | Met primary |
| Phase 3 | NCT01848054 Comparator | Jun 2013 → Jan 2014 | opiate dependence | Orexo AB | Completed | No outcome recorded |
| Phase 3 | NCT01717963 Comparator | Oct 2012 → Aug 2016 | opiate dependence | University of Oslo | Completed | Met primary |
| Phase 3 | NCT01476774 Comparator | Aug 2009 → Jun 2010 | intervertebral disk degenerative disorder | Mundipharma (China) Pharmaceutical Co. Ltd | Completed | Met primary |
| Phase 3 | NCT01046851 Comparator | Sep 2008 → Dec 2011 | — | Prof. Yoram Yovell | Unknown | No outcome recorded |
| Phase 3 | NCT00647127 Comparator | Feb 2008 → Aug 2009 | — | University of Aarhus | Completed | No outcome recorded |
| Phase 3 | NCT00863291 Comparator | Nov 2007 → Nov 2008 | depressive disorder | Abarbanel Mental Health Center | Unknown | No outcome recorded |
| Phase 3 | NCT00447564 Comparator | Oct 2006 → Jul 2008 | opiate dependence | Titan Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02516436 Comparator | ? → May 2017 | opiate dependence | BioDelivery Sciences International | Withdrawn | No outcome recorded |
| Phase 4 | NCT07097493 Comparator | Aug → Dec 2026 expected | osteoarthritis, knee | Wake Forest University Health Sciences | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06880718 Comparator | Feb 2026 → Jan 2027 expected | opiate dependence | Lifespan | Recruiting | No outcome recorded |
| Phase 4 | NCT06051890 Comparator | Jun 2025 → Dec 2026 expected | opiate dependence | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 4 | NCT06742554 Comparator | Dec 2024 → Apr 2025 overdue | — | medina medical center | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06323824 Comparator | Jun 2024 → Dec 2028 expected | substance-related disorder | Yale University | Recruiting | No outcome recorded |
| Phase 4 | NCT05594121 Comparator | Dec 2022 → Dec 2023 | opiate dependence | Royal Victoria Hospital, Canada | Unknown | No outcome recorded |
| Phase 4 | NCT05419297 Comparator | Aug 2022 → Jul 2023 | chronic pain syndrome | Carolinas Pain Institute | Unknown | No outcome recorded |
| Phase 4 | NCT04771689 Comparator | Jul 2022 → Dec 2025 | — | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03845894 Comparator | Mar 2020 → Jun 2022 | — | Wake Forest University Health Sciences | Terminated | No outcome recorded |
| Phase 4 | NCT04212065 Comparator | Feb → Sep 2020 | substance-related disorder | Ohio State University | Withdrawn | No outcome recorded |
| Phase 4 | NCT04234516 Comparator | Jan 2020 → Jun 2021 | opiate dependence | New York State Psychiatric Institute | Withdrawn | No outcome recorded |
| Phase 4 | NCT04464512 Comparator | Jan 2020 → Aug 2021 | chronic pain syndrome, disease of bone structure, opiate dependence | West Virginia University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03740243 Comparator | Nov 2018 → Mar 2020 | substance-related disorder | Stony Brook University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02267057 Comparator | Aug 2014 → Dec 2016 | dementia, depressive disorder | University of Bergen | Completed | No outcome recorded |
| Phase 4 | NCT02162121 Background | May 2014 → Oct 2016 | — | ASST Gaetano Pini-CTO | Completed | No outcome recorded |
| Phase 4 | NCT01843023 Comparator | Jun 2013 → Jan 2018 | drug dependence | Friends Research Institute, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01854489 Comparator | Apr 2013 → Nov 2014 | — | Turku University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01298297 Comparator | Feb 2010 → Mar 2011 | — | Tehran University of Medical Sciences | Completed | No outcome recorded |
| Phase 4 | NCT01015066 Comparator | Nov 2009 → Jun 2014 | opiate dependence | State University of New York at Buffalo | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT00916890 Comparator | Feb 2009 → Feb 2015 | chronic pain syndrome | Fondazione IRCCS Policlinico San Matteo di Pavia | Suspended | No outcome recorded |
| Phase 4 | NCT00605033 Comparator | Mar 2008 → Apr 2009 | opiate dependence | Indivior Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00684073 Background | Jul → Dec 2007 | opiate dependence, substance abuse | Indivior Inc. | Completed | Missed primary |
| — | NCT05270434 Background | Mar → Oct 2025 | chronic pancreatitis | Changhai Hospital | Completed | No outcome recorded |
| — | NCT05091138 Comparator | Oct 2021 → Oct 2022 | — | Wayne State University | Unknown | No outcome recorded |
| — | NCT05090761 Comparator | Oct 2021 → Oct 2022 | — | Wayne State University | Unknown | No outcome recorded |
| — | NCT03586466 Background | Dec 2018 → Sep 2020 | opiate dependence | MedicaSafe, Inc. | Unknown | No outcome recorded |
| — | NCT02971475 Background | Nov 2016 → May 2019 | chronic pancreatitis | Changhai Hospital | Unknown | No outcome recorded |
| — | NCT02659787 Comparator | Jun 2016 → Apr 2017 | depressive disorder | University of Chicago | Completed | No outcome recorded |
| — | NCT02136784 Comparator | Apr → Dec 2014 | — | University of California, Los Angeles | Unknown | No outcome recorded |
| — | NCT01550341 Comparator | Feb 2012 → Nov 2015 | AIDS, opiate dependence | Yale University | Completed | No outcome recorded |
| — | NCT00929253 Comparator | Sep 2007 → Apr 2010 | opiate dependence | Virginia Polytechnic Institute and State University | Completed | No outcome recorded |
| — | NCT00249574 Background | Jun 2003 → Mar 2004 | hepatitis C virus infection, heroin dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 164
| Date | Issuer | Release |
|---|---|---|
| 2026-05-28 | Braeburn Pharmaceuticals | Results Braeburn Presents New Data at 2026 ASCP Annual Meeting Demonstrating Opioid Withdrawal Suppression at Low Buprenorphine Plasma Concentrations braeburnrx.com ↗
Suppression of opioid withdrawal following a single dose CAM2038 32 mg weekly and 128 mg monthly, which was sustained throughout the dosing interval, including in participants with buprenorphine plasma concentrations <0.5 ng/mL. |
| 2026-05-20 | Indivior Inc. | Results New Studies Show Adherence to Monthly Injectable Buprenorphine is Associated with Relapse Reduction and Lower Healthcare Utilization indivior.com ↗
Compared to patients adherent to monthly injectable buprenorphine, patients on other MOUD (adherent and non-adherent) were 3.5 to 8.1x more likely to return to opioid use. |
| 2026-04-24 | Indivior Inc. | Results Indivior Presents New Real-World Data at ASAM 2026 Annual Conference, Supporting Remission as a Treatment Outcome and Reinforcing the Clinical Benefits of Monthly Injectable Buprenorphine for Opioid Use Disorder indivior.com ↗
Of all MOUD, SUBLOCADE accounted for the smallest proportion of non-fatal and fatal OD events compared to no treatment. |
| 2026-04-16 | Indivior Inc. | Results Survey of Correctional Facility Staff: Monthly Opioid Treatment Shot May Help Reduce Medication Misuse indivior.com ↗
Among respondents, a strong majority — 88% of those working in jails and 87% in prisons — reported that LAI buprenorphine could help reduce MOUD diversion within their facilities. |
| 2026-03-17 | Braeburn Pharmaceuticals | Results NIH-Funded Randomized Clinical Trial Evaluating Weekly BRIXADI® for Opioid Use Disorder in Pregnancy and 12-months Postpartum Published in JAMA Internal Medicine braeburnrx.com ↗
The study met its primary and key secondary endpoint of non-inferiority to sublingual. |
| 2026-03-11 | Indivior Inc. | Results New Study Shows Adherence to Monthly Injectable Buprenorphine Linked to Lower Healthcare Utilization and Costs in Opioid Use Disorder indivior.com ↗
Patients adherent to SUBLOCADE for 12 months had 42% lower adjusted non-MOUD medical costs vs. those adherent to other forms of MOUD |
| 2025-12-17 | Indivior Inc. | Results New Study Shows Extended-Release Buprenorphine Safely Delivers Rapid, Clinically Meaningful Reductions in Opioid Use and Supports Abstinence in High-Risk Populations indivior.com ↗
Both monthly maintenance doses (100 mg and 300 mg) improved opioid abstinence and were well-tolerated with no new safety signals identified. |
| 2025-11-03 | Indivior Inc. | Results Indivior Presents New Real-World Evidence at AMCP Nexus 2025 Demonstrating Clinical and Economic Benefits of Adherence to Monthly Injectable Buprenorphine indivior.com ↗ |
| 2025-10-15 | Indivior Inc. | Results Clinical Evidence Supports Rapid SUBLOCADE® Induction as a Strategy to Improve Retention in Opioid Use Disorder Treatment indivior.com ↗
These benefits were observed across the full study population and were especially pronounced among fentanyl-positive participants, addressing the clinically relevant outcome that patients remain engaged with treatment after induction. |
| 2025-07-23 | Indivior Inc. | Results Indivior Real World Evidence Study Finds Medications for Opioid Use Disorder, Particularly Extended-Release Buprenorphine, Reduced Odds of Emergency Department Visits for Patients with Opioid Use Disorder indivior.com ↗
The study found that patients treated with BUP-XR, in the form of the once-monthly long-acting injectable formulation of buprenorphine, had 57% lower odds of all-cause ED visits compared to those who received no MOUD. |
| 2025-06-19 | Indivior Inc. | Results Indivior Presents New Data at CPDD Demonstrating that High Buprenorphine Exposure May Improve Treatment Outcomes in High Fentanyl Users indivior.com ↗
A post hoc analysis showed that patients with heavier fentanyl use experienced clinically meaningful improvements in opioid abstinence when treated with a 300 mg maintenance dose of SUBLOCADE, compared to the 100 mg dose. |
| 2025-05-01 | Indivior Inc. | Results New Study Highlights Monthly SUBLOCADE® as a Potential Treatment Option for Opioid Use Disorder During and After Pregnancy indivior.com ↗
Three sources of data evaluated in this retrospective study illustrated that the use of monthly SUBLOCADE during pregnancy demonstrated no increased risk and is consistent with the established buprenorphine safety profile. |
| 2025-02-24 | Indivior Inc. | Regulatory Indivior Announces FDA Approval of Label Changes for SUBLOCADE® (buprenorphine extended-release) Injection indivior.com ↗
Healthcare providers can now initiate treatment with SUBLOCADE after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability. |
| 2025-02-12 | Indivior Inc. | Regulatory Indivior Statement RE: Delayed FDA Approval of SUBLOCADE® Label Changes indivior.com ↗
Yesterday, February 11th, the FDA informed Indivior that, following acceptance of the proposed label for SUBLOCADE, there were no outstanding items to address, but that final review of the SUBLOCADE label changes has been delayed. |
| 2024-11-19 | Indivior Inc. | Results Indivior | Rapid Initiation with Once-monthly SUBLOCADE® Superior to Standard Initiation for Treating Opioid Use Disorder, Including in Fentanyl-Positive Patients, According to Data Presented at CSAM 2024 indivior.com ↗
Data show rapid initiation with once-monthly SUBLOCADE significantly improves retention in opioid use disorder (OUD) patients, especially among fentanyl-positive participants. |
| 2024-10-30 | Indivior Inc. | Results Indivior | Indivior Highlights Growing Body of Data on SUBLOCADE® (buprenorphine once-monthly extended release injection) Helping Patients Achieve Long-Term Recovery from Opioid Use Disorder during Substance Abuse Prevention Month indivior.com ↗
However, both were equally effective in non-injecting participants. |
| 2024-10-07 | Indivior Inc. | Regulatory lndivior's SUBLOCADE" Rapid Induction/Alternative Injection Site Prior Approval Supplement (PAS) Receives FDA Priority Review indivior.com ↗
lndivior PLC (Nasdaq/LSE: INDV) today announced the Prior Approval Supplement (PAS) for SUBLOCADE• (buprenorphine extended-release) injection submitted by lndivior, Inc. has been granted Priority Review designation by the U.S. Food and Drug Administration (FDA). |
| 2024-06-25 | Camurus AB | Results New publication shows effectiveness data for weekly and monthly buprenorphine injections in treating opioid dependence in individuals using fentanyl camurus.com ↗
The data presented suggests the effectiveness in individuals with opioid dependence who use fentanyl, consistent with the results from the Phase 3 study. |
| 2024-06-25 | Braeburn Pharmaceuticals | Results Braeburn Announces Publication of a Post Hoc Analysis of Data from Patients Using Fentanyl Treated with BRIXADI® in a Phase 3 Efficacy and Safety Study braeburnrx.com ↗ |
| 2023-10-11 | Orexo AB | Results Orexo announces data from the MODIA® study evaluating impact on use of illicit opioids orexo.com ↗
The study had unexpectedly high treatment response rates for both treatment arms, with no statistically significant difference in treatment response in the full population. |
| 2023-05-23 | Camurus AB | Regulatory Camurus announces FDA approval of Brixadi™ for the treatment of moderate to severe opioid use disorder camurus.com ↗ |
| 2023-05-23 | Braeburn Pharmaceuticals | Regulatory Braeburn’s BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection (CIII) Receives FDA Approval for Moderate to Severe Opioid Use Disorder braeburnrx.com ↗
“Today’s FDA approval of BRIXADI is a significant step forward in the fight against OUD,” said Mike Derkacz, President and CEO of Braeburn. |
| 2023-02-13 | Camurus AB | Regulatory Camurus withdraws variation application for CAM2038 to include chronic pain camurus.com ↗
Camurus (NASDAQ STO: CAMX) announced today that it has notified the European Medicines Agency (EMA) of its decision to withdraw the Type II variation application for CAM2038 to include treatment of chronic pain in patients with opioid dependence. |
| 2022-12-08 | Camurus AB | Regulatory Camurus announces PDUFA date for Brixadi™ NDA for the treatment of opioid use disorder in the US camurus.com ↗ |
| 2022-12-08 | Braeburn Pharmaceuticals | Regulatory FDA Accepts Braeburn’s New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder braeburnrx.com ↗
Braeburn announces that the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly injections for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was accepted by the U.S. Food and Drug Administration (FDA). |
| 2022-11-23 | Camurus AB | Regulatory Camurus announces that Braeburn resubmits NDA for Brixadi™ in the US camurus.com ↗
Camurus AB (NASDAQ STO: CAMX) today announced that its US licensee Braeburn Inc. has resubmitted the New Drug Application (NDA) for Brixadi* (buprenorphine) extended-release injection for subcutaneous (SC) use (Schedule III Controlled Substance) for the treatment of moderate to severe opioid use disorder to the US Food and Drug Administration (FDA). |
| 2022-11-23 | Braeburn Pharmaceuticals | Regulatory Braeburn Resubmits New Drug Application for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder braeburnrx.com ↗
Braeburn announces that the company has resubmitted to the U.S. Food and Drug Administration (FDA) its New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder. |
| 2022-08-25 | Indivior Inc. | Results Indivior | Indivior Publishes Exploratory Study Showing That Access to Medication for Opioid Use Disorder Varies Across Organized Health Systems in the U.S. indivior.com ↗
Overall, the distribution of BUP-XR as a treatment option for patients with OUD increased within OHS but occurred at different rates across OHS subtypes. |
| 2022-05-26 | Indivior Inc. | Results Indivior | Indivior Announces Publication of Data Showing Psychosocial Benefits from a 4-year Post-Clinical Trial Outcomes Study indivior.com ↗
In this follow-up study, high opioid abstinence rates were also reported (55 percent from the last RECOVER study assessment and 69 percent over the past 30 days). |
| 2022-04-08 | Indivior Inc. | Results Indivior | Indivior Publishes Modeling Data Showing Buprenorphine May Mitigate Fentanyl-Induced Respiratory Depression in Chronic Opioid Users indivior.com ↗
Indivior PLC (LON: INDV) announces the publication of modeling data examining the competitive interaction between buprenorphine, a treatment for opioid use disorder (OUD), and fentanyl, a potent synthetic opioid, to better understand how buprenorphine can reduce fentanyl-induced respiratory depression. |
| 2022-04-01 | Indivior Inc. | Results Indivior | Indivior Presents New Integrated Analysis Evaluating Long-Term Benefits of SUBLOCADE® (buprenorphine-extended release) Injection indivior.com ↗
The continued use of treatment beyond six months provided additional improvement in opioid abstinence for patients with less favorable early treatment response, while the incidence of treatment-emergent adverse events (TEAEs) decreased over time. |
| 2022-01-27 | Indivior Inc. | Results Research Indicates Sustained High Plasma Concentrations of Buprenorphine Reduce Fentanyl lnduced Respiratory Depression in Opioid-Tolerant Participants indivior.com ↗ |
| 2021-12-15 | Camurus AB | Regulatory Braeburn receives new Complete Response Letter for Brixadi in the US camurus.com ↗ |
| 2021-12-08 | Indivior Inc. | Results Indivior | Indivior to Present New Data on Buprenorphine Extended-Release at the 2021 Joint International Congress with ALBATROS and the World Association on Dual Disorder (WADD) indivior.com ↗
The results showed that the safety and efficacy of SUBLOCADE® was consistent across subgroups compared to placebo. |
| 2021-11-30 | Camurus AB | Regulatory The European Medicines Agency accepts application to extend the Buvidal indication to include treatment of chronic pain camurus.com ↗
Sweden — 30 November 2021 — Camurus (NASDAQ STO: CAMX) today announces that the European Medicines Agency (EMA) has accepted the company’s submission of a Type II variation application for Buvidal® (buprenorphine) prolonged release injection to include treatment of chronic pain. |
| 2021-11-08 | Indivior Inc. | Results Indivior | Indivior Presents Modelling Data on Interaction Between Buprenorphine and Fentanyl in Opioid-Naïve and Opioid-Tolerant Subjects at the 2021 American Conference of Pharmacometrics indivior.com ↗
This modelling suggested that clinically relevant exposures to buprenorphine has the potential to limit fentanyl binding to MORs and thereby possibly reduce the frequency and magnitude of respiratory depression induced by fentanyl in opioid-tolerant (OT) subjects. |
| 2021-11-01 | Indivior Inc. | Results Indivior | Indivior Presents Study at the 2021 National Commission on Correctional Healthcare Conference on Factors Impacting Medications for Opioid Use Disorder Treatment Approaches in Criminal Justice-Involved Populations indivior.com ↗
The interviews revealed that all eight addiction medicine team members favored the use of the monthly injectable version of buprenorphine for most people with OUD. |
| 2021-06-26 | Camurus AB | Regulatory Camurus announces PDUFA date for Brixadi for the treatment of opioid use disorder in the US camurus.com ↗
The Prescription Drug User Fee Act (PDUFA) action date is set for 15 December 2021. |
| 2021-06-26 | Braeburn Pharmaceuticals | Regulatory FDA Accepts Braeburn’s New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder braeburnrx.com ↗
Braeburn announces that the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was accepted by the U.S. Food and Drug Administration (FDA). |
| 2021-06-15 | Camurus AB | Regulatory Camurus announces Braeburn resubmits New Drug Application for Brixadi™ in the US camurus.com ↗
The resubmission is in response to the Complete Response Letter (CRL) issued by the FDA to Braeburn on 1 December 2020 citing deficiencies identified during a pre-approval inspection of Braeburn’s third-party manufacturer in the US. |
| 2021-06-15 | Braeburn Pharmaceuticals | Regulatory Braeburn Resubmits New Drug Application for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder braeburnrx.com ↗
Braeburn announces that today the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was resubmitted to the U.S. Food and Drug Administration (FDA). |
| 2021-05-10 | Camurus AB | Results Camurus announces publication showing superior patient treatment satisfaction with Buvidal® weekly and monthly depot injections in opioid dependence camurus.com ↗
The primary endpoint was met with statistically higher patient global satisfaction with the depot buprenorphine treatment |
| 2021-05-03 | Camurus AB | Regulatory The Australian TGA approves key label updates to Buvidal® for treatment of opioid dependence camurus.com ↗
Camurus AB (NASDAQ STO: CAMX) today announced that the Australian regulatory agency, the Therapeutic Goods Administration (TGA), has approved key label updates to Buvidal® Weekly and Buvidal® Monthly (buprenorphine) modified-release solutions for injection. |
| 2021-03-26 | Camurus AB | Regulatory Camurus receives positive CHMP opinion for Buvidal 160mg monthly dose for the treatment of opioid dependence camurus.com ↗
Camurus today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency’s (EMA) has issued a positive opinion recommending marketing authorization for a new, 160mg, monthly dose of Buvidal® (buprenorphine) prolonged release injection for the treatment opioid dependence in adults and adolescents from 16 years of age. |
| 2020-12-18 | Camurus AB | Regulatory Swissmedic approves Buvidal for the treatment of opioid dependence camurus.com ↗ |
| 2020-12-02 | Camurus AB | Regulatory Camurus announces that Braeburn receives Complete Response Letter for Brixadi for opioid use disorder in the US camurus.com ↗
The CRL follows a recent pre-approval inspection of Braeburn’s third-party manufacturer of Brixadi in the US, during which quality related deficiencies were identified. |
| 2020-12-02 | Braeburn Pharmaceuticals | Regulatory Braeburn Receives Complete Response Letter for the NDA for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder braeburnrx.com ↗
Braeburn announces that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection for subcutaneous (SC) use (CIII) for the treatment of moderate to severe opioid use disorder. |
| 2020-06-24 | Indivior Inc. | Results Indivior | New Data from the RECOVER™ Study Reveal Two-Year Outcomes in People with Opioid Use Disorder Following Transition from Pivotal Phase 3 Clinical Trials to a Real-World Setting indivior.com ↗
Indivior PLC (LON: INDV) announces new data from the two-year analysis of the 24-month real-world observational study, RECOVER™ (Remission from Chronic Opioid Use—Studying Environmental and SocioEconomic Factors on Recovery). |
| 2020-06-01 | Camurus AB | Regulatory Camurus announces submission of request for final approval of Brixadi™ for the treatment of opioid use disorder in the US camurus.com ↗
With today’s request, Braeburn has submitted all updates for a final approval decision in the US on 1 December 2020. |
| 2020-06-01 | Braeburn Pharmaceuticals | Regulatory Braeburn Submits Request for Final Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder braeburnrx.com ↗
Braeburn announces that it has requested final approval from the U.S. Food and Drug Administration (FDA) of the New Drug Application for BRIXADI™ (buprenorphine) weekly and monthly extended-release injection for the treatment of opioid use disorder (OUD). |
| 2020-05-06 | Indivior Inc. | Regulatory Indivior | Indivior receives approval for SUBUTEX® prolonged release solution for injection, 100mg and 300mg for substitution treatment of opioid dependence in Sweden indivior.com ↗
This marks the first approval of Indivior’s monthly long acting buprenorphine treatment for opioid dependence in Europe. |
| 2020-04-16 | Indivior Inc. | Results Indivior | SUBLOCADE® Long-Term Safety Data Published in Journal of Clinical Psychopharmacology indivior.com ↗
The safety profile of up to 12-month SUBLOCADE treatment was consistent with that of transmucosal buprenorphine, with the exception of the anticipated injection-site reactions. |
| 2020-04-16 | Impax Laboratories, LLC | Regulatory Amneal Launches Generic Butrans® Following ANDA Approval by FDA amneal.com ↗
In addition, Amneal was granted the Competitive Generic Therapy (CGT) designation and 180 days of exclusivity for the 7.5 mcg/hr dose. |
| 2020-03-23 | Indivior Inc. | Results Indivior | One-Year Outcomes of Real-World RECOVER™ Study Published in Journal of Addiction Medicine indivior.com ↗
These findings show that long-term treatment may positively assist patients in focusing on their recovery, including re-engaging with family, friends and community. |
| 2019-12-02 | Indivior Inc. | Results Indivior | New Analysis From One-Year Study of Monthly Buprenorphine Extended-Release Injections Showed Improved or Stable Patient-Centered Outcomes indivior.com ↗
Sustained improvements in multiple health outcomes following twelve monthly buprenorphine extended-release injections in patients with opioid use disorder. |
| 2019-11-26 | Camurus AB | Results Camurus announces new study results showing superior patient reported outcomes with Buvidal® versus standard of care in treatment of opioid dependence camurus.com ↗
DEBUT study met the primary endpoint, demonstrating superior patient global satisfaction with Buvidal® vs daily sublingual buprenorphine |
| 2019-11-08 | Camurus AB | Regulatory Camurus Interim Report January-September 2019 camurus.com ↗
FDA grants Braeburn’s Citizen Petition allowing Brixadi™ for treatment of opioid use disorder to be available in the US in December 2020 |
| 2019-11-08 | Camurus AB | Regulatory Camurus announces that FDA grants Braeburn’s Citizen Petition, eliminating the risk of further blocking of Brixadi™ from the US market camurus.com ↗
Lund — 8 November 2019 — Camurus AB (NASDAQ STO: CAMX) today announces that the U.S. Food and Drug Administration (FDA) has granted Camurus’ US partner Braeburn’s request (through Citizen Petition) to revoke orphan drug designation of Sublocade™. |
| 2019-11-07 | Braeburn Pharmaceuticals | Regulatory FDA Grants Braeburn’s Citizen Petition Allowing BRIXADI (buprenorphine) Extended-Release Injection for Opioid Use Disorder to be Available in December 2020 braeburnrx.com ↗
This follows from today’s decision by the U.S. Food and Drug Administration (FDA) to grant Braeburn’s Citizen Petition (filed in April 2019) and thereby revoke Indivior PLC’s orphan designation for buprenorphine treatment for OUD. |
| 2019-10-22 | Titan Pharmaceuticals | Results Titan Pharmaceuticals To Present Two Posters On Probuphine® At The 10th American Conference On Pharmacometrics titanpharm.com ↗
The population PK study found that the only significant demographic impacts on buprenorphine absorption and clearance from Probuphine treatment were body mass index and body weight, respectively. |
| 2019-08-26 | Camurus AB | Regulatory Australian Minister for Health announced PBS listing of Buvidal® Weekly and Monthly for treatment of opioid dependence camurus.com ↗
The Australian Federal Health Minister Greg Hunt announced on Sunday that Camurus’ long-acting medication Buvidal® Weekly and Monthly (buprenorphine) solutions for injection will be listed on the PBS. |
| 2019-07-23 | Braeburn Pharmaceuticals | Regulatory U.S. District Court Orders FDA to Reconsider Application for Final Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder braeburnrx.com ↗
Braeburn’s application for final approval of BRIXADI is remanded back to FDA for reconsideration “with deliberate speed.” |
| 2019-06-26 | Titan Pharmaceuticals | Regulatory Titan Pharmaceuticals And Molteni Receive European Regulatory Approval For Probuphine titanpharm.com ↗
Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) today announced that the European Commission ("EC") has approved Sixmo ® -buprenorphine, the brand name for Probuphine ® (buprenorphine) implant in the European Union ("EU"). |
| 2019-06-17 | Indivior Inc. | Results Indivior | New Data from the RECOVER™ Study Reports on Abstinence, Drug Craving and Psychosocial Outcomes in People with Opioid Use Disorder following Transition from a Clinical Trial to the Real-World Setting indivior.com ↗ |
| 2019-06-04 | Camurus AB | Results Camurus announces publication of Phase 3 study results showing long-term safety, efficacy and high rates of patient satisfaction with Buvidal® camurus.com ↗
The study confirmed the safety and efficacy of Buvidal® in both new-to-treatment patients and patients transferring from standard of care with daily sublingual buprenorphine/naloxone. |
| 2019-06-04 | Braeburn Pharmaceuticals | Results Braeburn Announces Publication of Phase 3 Study Results Showing Long-term Safety and Effectiveness of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder braeburnrx.com ↗
Individualized treatment with BRIXADI weekly and monthly was well-tolerated and effective, with a high (73.6%) treatment retention of patients throughout the 48-week study period. |
| 2019-04-29 | Titan Pharmaceuticals | Regulatory Titan Pharmaceuticals And Molteni Announce Positive EU CHMP Opinion For Probuphine® titanpharm.com ↗
The CHMP's positive opinion of Sixmo will now be transmitted to the EC, which is expected to issue the Commission Decision for Sixmo for all 28 member states of the EU around the end of June 2019. |
| 2019-04-08 | Indivior Inc. | Results Indivior | Indivior Announces New Study Data in Patients with Moderate to Severe Opioid Use Disorder (OUD) at the 50th ASAM Annual Conference indivior.com ↗
This study of eight opioid-tolerant patients showed that buprenorphine plasma concentrations of 2ng/mL and higher that were achieved following intravenous infusion reduced the extent of respiratory depression from fentanyl. |
| 2019-04-06 | Camurus AB | Results Positive treatment results for Buvidal® in fentanyl users presented at the ASAM 50th Annual Conference camurus.com ↗
Camurus announces positive post-hoc analyses results from the randomized, double-blind, double-dummy Phase 3 study of CAM2038 (Buvidal®, buprenorphine prolonged-release solution for subcutaneous injection) for the treatment of opioid dependent patients with evidence of fentanyl use prior to treatment initiation. |
| 2019-04-06 | Braeburn Pharmaceuticals | Results Positive Treatment Results for BRIXADI™ (buprenorphine) Extended-Release Injection in Fentanyl Positive Patients Presented at the 50th Conference of the American Society of Addiction Medicine braeburnrx.com ↗ |
| 2019-04-05 | Indivior Inc. | Results Indivior | Indivior’s RECOVER™ Study Finds Three-quarters of Patients with Moderate to Severe Opioid Use Disorder Who Received 12 monthly Injections of SUBLOCADE™ (Buprenorphine Extended-Release) Injection were Abstinent from Illicit Opioids One Year Later indivior.com ↗
The RECOVER™ study found that 75 percent of patients who had received 12 once-monthly doses of SUBLOCADE in a Phase 3 clinical trial were abstinent from illicit opioids for a year after the study ended. |
| 2019-03-07 | Indivior Inc. | Results Indivior | The Journal of Addiction Medicine Publishes Patient-centered Outcomes from the Phase 3 Study of SUBLOCADE™ (Buprenorphine Extended-Release) Injection in Patients with Moderate to Severe Opioid Use Disorder (OUD) indivior.com ↗
Six monthly injections of SUBLOCADE™ improved patient health status and health-related quality of life compared to placebo in 24-week pivotal trial |
| 2019-02-19 | Indivior Inc. | Results Indivior | The Lancet Publishes Phase 3 Results Demonstrating Efficacy, Safety and Tolerability of SUBLOCADE™ (Buprenorphine Extended-Release) Injection for Subcutaneous Use (CIII) in Patients with Moderate to Severe Opioid Use Disorder (OUD) indivior.com ↗
SUBLOCADE – the first FDA-approved monthly injectable buprenorphine treatment for OUD – met primary and key secondary endpoints in the 24-week pivotal trial |
| 2018-12-23 | Camurus AB | Regulatory US FDA issues a tentative approval of Brixadi™ (buprenorphine) extended-release injection for treatment of opioid use disorder camurus.com ↗
With the tentative approval, Brixadi has met all regulatory standards of clinical and non-clinical safety, efficacy and quality for US approval. |
| 2018-12-23 | Braeburn Pharmaceuticals | Regulatory Braeburn Announces Tentative FDA Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Moderate to Severe Opioid Use Disorder braeburnrx.com ↗
Braeburn today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval of BRIXADI (buprenorphine) extended-release weekly (8mg, 16mg, 24mg, 32mg) and monthly (64 mg, 96mg, 128mg) injections. |
| 2018-11-28 | Camurus AB | Regulatory Buvidal® Weekly and Buvidal® Monthly (CAM2038) approved in Australia as the first long-acting treatment of opioid dependence camurus.com ↗
Camurus announced today that the Australian Therapeutic Goods Administration (TGA) has approved the company’s lead products Buvidal® Weekly and Buvidal® Monthly (CAM2038) for maintenance treatment of opioid dependence within a framework of medical, social and psychosocial support. |
| 2018-11-23 | Indivior Inc. | Regulatory Indivior | Indivior Announces Health Canada Approval of SUBLOCADE™ (Buprenorphine Extended-Release) Injection for Patients with Moderate to Severe Opioid Use Disorder indivior.com ↗
SUBLOCADE is the first and only once-monthly injectable buprenorphine formulation approved in Canada for the management of moderate to severe opioid use disorder |
| 2018-11-22 | Camurus AB | Regulatory Camurus receives EU approval for weekly and monthly Buvidal® (CAM2038) for opioid dependence camurus.com ↗
Camurus announced today that the European Commission (EC) has approved weekly and monthly Buvidal® (prolonged release buprenorphine) for the treatment of opioid dependence in adults and adolescents from 16 years of age. |
| 2018-10-29 | Alkermes, Inc. | Results Alkermes Announces Publication of Phase 3 Data for ALKS 5461 for Adjunctive Treatment of Major Depressive Disorder in Molecular Psychiatry alkermes.com ↗
The Molecular Psychiatry publication includes comprehensive efficacy and safety results from FORWARD-4 (Study 205) and FORWARD-5 (Study 207), and a review of a pooled analysis of the two datasets. |
| 2018-09-21 | Camurus AB | Regulatory CHMP recommends approval of Buvidal® (CAM2038) for the treatment of opioid dependence camurus.com ↗
“The excellent news that the CHMP recommends approval of Buvidal® means that European patients and physicians could soon have access to a new and effective treatment for opioid dependence,” said Fredrik Tiberg, President and CEO of Camurus. |
| 2018-09-21 | Braeburn Pharmaceuticals | Regulatory CAM2038 Receives Positive CHMP Opinion for the Treatment of Opioid Dependence in Europe braeburnrx.com ↗
“The positive CHMP opinion represents a step forward in helping to address the unmet need for effective alternatives to treat opioid dependence for patients in Europe,” said Mike Derkacz, President and CEO of Braeburn. |
| 2018-09-18 | Camurus AB | Results Camurus announces positive topline Phase 3 results for CAM2038 in opioid experienced patients with chronic low-back pain camurus.com ↗
Camurus (NASDAQ STO: CAMX) today announced positive results from a Phase 3 efficacy study of CAM2038, weekly and monthly buprenorphine depots, in opioid experienced patients with chronic low-back pain. |
| 2018-09-18 | Braeburn Pharmaceuticals | Results Braeburn Announces Positive Top-line Phase 3 Results for CAM2038 in Chronic Low Back Pain Patients Previously on Long-term Daily Opioid Therapy braeburnrx.com ↗
The study met its primary efficacy endpoint of Average Pain Intensity (API), demonstrating that patients with CLBP receiving treatment with CAM2038 experienced statistically significant reduction in pain compared with placebo (p < 0.001, mITT, effect size 1.03). |
| 2018-07-17 | Camurus AB | Regulatory Interim Report January-June 2018 camurus.com ↗
FDA accepts complete response and issues user fee (PDUFA) goal date of December 26, 2018 |
| 2018-07-16 | Camurus AB | Regulatory Camurus announces PDUFA date for CAM2038 for the treatment of opioid use disorder camurus.com ↗
The FDA considers the resubmission of the New Drug Application (NDA) by Camurus’ US partner Braeburn a complete response to the January 19, 2018, action letter. |
| 2018-07-16 | Braeburn Pharmaceuticals | Regulatory Braeburn Announces PDUFA Date for CAM2038 for the Treatment of Opioid Use Disorder braeburnrx.com ↗
Braeburn announces that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2018 for its New Drug Application (NDA) for CAM2038 |
| 2018-05-28 | Camurus AB | Regulatory Camurus announces NDA resubmission of weekly and monthly buprenorphine depots to FDA camurus.com ↗ |
| 2018-05-28 | Braeburn Pharmaceuticals | Regulatory Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder braeburnrx.com ↗
Braeburn announces the resubmission of the New Drug Application (NDA) for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly depot injection for the treatment of opioid use disorder (OUD). |
| 2018-05-25 | Indivior Inc. | Regulatory Indivior | Indivior Announces Regulatory Submission to Australia’s Therapeutic Goods Administration (TGA) for SUBLOCADE™ (Buprenorphine Extended-Release) Injection for the Treatment of Opioid Dependence indivior.com ↗ |
| 2018-05-14 | Camurus AB | Results JAMA Internal Medicine publishes positive Phase 3 pivotal study results for Camurus’ long-acting buprenorphine depots for opioid use disorder camurus.com ↗
Today’s publication of the Phase 3 results suggests that treatment of opioid use disorder (OUD) with buprenorphine can be improved with weekly and monthly depot formulations, CAM2038. |
| 2018-05-14 | Braeburn Pharmaceuticals | Results Braeburn Announces Publication of Positive Phase 3 Results For Long-Acting Buprenorphine For Treatment Of Opioid Use Disorder in JAMA Internal Medicine braeburnrx.com ↗
In this study, CAM2038 met the primary endpoint of non-inferiority versus daily sublingual buprenorphine/naloxone (current Standard of Care) and demonstrated superiority for the key secondary endpoint. |
| 2018-04-20 | Indivior Inc. | Regulatory Indivior | Indivior Announces New Drug Submission to Health Canada for SUBLOCADE™ (Buprenorphine Extended-Release) Injection for the Treatment of Moderate to Severe Opioid Use Disorder indivior.com ↗ |
| 2018-04-20 | Knight Therapeutics (USA) Inc | Regulatory Knight Therapeutics Announces Canadian Regulatory Approval for PROBUPHINE™ for Opioid Drug Dependence knighttx.com ↗
“We are thrilled that PROBUPHINE™ has received approval by Health Canada,” said Mike Derkacz, President and CEO of Braeburn. |
| 2018-04-13 | Indivior Inc. | Results Indivior | Patient-Reported Outcomes Data on SUBLOCADEᵀᴹ (Buprenorphine Extended-Release) Injection to be Presented as Late-Breaker at American Society of Addiction Medicine (ASAM) 49ᵗʰ Annual Conference indivior.com ↗
Results showed that, in general, patients with moderate to severe OUD who were treated with SUBLOCADE demonstrated improved patient-reported health outcomes that were sustained during the study period. |
| 2018-01-21 | Camurus AB | Regulatory FDA issues complete response letter for CAM2038 for opioid use disorder camurus.com ↗
The FDA has issued a complete response letter that will serve as road map for approval and we are confident that the questions raised by the Agency can be effectively managed and resolved |
| 2018-01-21 | Braeburn Pharmaceuticals | Regulatory Braeburn Receives Complete Response Letter for CAM2038 Injectable Buprenorphine Depot braeburnrx.com ↗
Braeburn Pharmaceuticals, Inc. (Braeburn) today announced that it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the new drug application (NDA) for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD). |
| 2017-11-30 | Indivior Inc. | Regulatory Indivior | FDA Approves SUBLOCADE™ (Buprenorphine Extended-Release), the First and Only Once-Monthly Injectable Buprenorphine Formulation to Treat Moderate to Severe Opioid Use Disorder indivior.com ↗ |
| 2017-11-27 | Titan Pharmaceuticals | Regulatory European Medicines Agency Accepts Titan Pharmaceuticals' Marketing Authorization Application For Probuphine® titanpharm.com ↗
The acceptance marks the beginning of the EMA's regulatory review process for Probuphine for substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. |
| 2017-11-20 | Orexo AB | Regulatory Zubsolv® receives authorization for treatment of opioid dependence in Europe orexo.com ↗
Uppsala, Sweden – November 20, 2017 – Orexo AB (publ.) today announce that the European Medicines Agency (EMA) has granted a Marketing Authorization (MA) for Zubsolv (buprenorphine and naloxone), a novel rapidly-disintegrating treatment option for opioid dependence. |
| 2017-11-14 | Alkermes, Inc. | Results VIVITROL® and Value of Medication-Assisted Treatment for Opioid Dependence Featured in Study Sponsored by National Institute on Drug Abuse alkermes.com ↗
Results from a National Institute on Drug Abuse (NIDA)-funded study, were published in The Lancet today, comparing extended-release naltrexone (VIVITROL®) and buprenorphine-naloxone, two options for opioid dependence. |
| 2017-11-01 | Camurus AB | Regulatory Camurus announces that FDA advisory committee recommends approval of CAM2038 for treatment of opioid use disorder camurus.com ↗
Camurus (NASDAQ STO: CAMX) today announced that the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 recommending approval of CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD). |
| 2017-11-01 | Braeburn Pharmaceuticals | Regulatory Braeburn Announces FDA Advisory Committee Recommends Approval of CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder braeburnrx.com ↗
The Committees voted 17 in favor of approval of some of the proposed doses and 3 in favor of none of the proposed doses of CAM2038. |
| 2017-10-31 | Indivior Inc. | Regulatory Indivior | FDA Advisory Committees Recommend Approval of Indivior’s RBP-6000 for the Treatment of Opioid Use Disorder indivior.com ↗
Indivior PLC (LON: INDV) announced today that the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 18 to 1 to recommend approval of RBP-6000 for the treatment of opioid use disorder (OUD). |
| 2017-10-18 | Alkermes, Inc. | Results New Study Comparing Effectiveness of Extended-Release Naltrexone to Buprenorphine-Naloxone for Opioid Dependence Published in JAMA Psychiatry alkermes.com ↗
Ten patients discontinued treatment due to adverse events: four in the extended-release naltrexone group and six in the buprenorphine-naloxone group. |
| 2017-10-03 | Indivior Inc. | Regulatory Indivior | FDA Posts Advisory Committee Meeting Notice for RBP-6000 NDA indivior.com ↗ |
| 2017-09-29 | Camurus AB | Regulatory Camurus announces European Medicines Agency validation of CAM2038 Marketing Authorization Application for treatment of opioid dependence camurus.com ↗
Camurus (NASDAQ STO: CAMX) today announced the company’s Marketing Authorization Application (MAA) for the investigational, weekly and monthly CAM2038 buprenorphine depots for the treatment of opioid dependence has been fully validated by the European Medicines Agency (EMA). |
| 2017-09-18 | Camurus AB | Regulatory Camurus Announces that FDA Grants Priority Review of NDA for Weekly and Monthly CAM2038 Buprenorphine Depots for Treatment of Opioid Use Disorder camurus.com ↗ |
| 2017-09-18 | Braeburn Pharmaceuticals | Regulatory FDA Acceptance of NDA for CAM2038 for Opioid Use Disorder braeburnrx.com ↗
Braeburn Announces FDA Acceptance with Priority Review of New Drug Application for CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder |
| 2017-09-15 | Orexo AB | Regulatory CHMP positive opinion for opioid dependence treatment with Zubsolv® (buprenorphine and naloxone) in Europe orexo.com ↗
Mundipharma and Orexo AB (publ.) today announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Zubsolv (buprenorphine and naloxone sublingual tablet) for use in the treatment of opioid dependence. |
| 2017-07-31 | Indivior Inc. | Regulatory Indivior | Indivior RBP-6000 NDA Acceptance with Priority Review Designation indivior.com ↗ |
| 2017-07-20 | Camurus AB | Regulatory Camurus and Braeburn Announce Submission of NDA for Long-Acting Buprenorphine (CAM2038) for Opioid Use Disorder camurus.com ↗
Braeburn has also applied for Priority Review which if granted could shorten the review process of CAM2038 following FDA’s acceptance of the NDA. |
| 2017-07-20 | Braeburn Pharmaceuticals | Regulatory Braeburn and Camurus Announce Submission for CAM2038 for Opioid Use Disorder braeburnrx.com ↗
Braeburn and Camurus Announce Submission of NDA for Long-Acting Buprenorphine (CAM2038) for Opioid Use Disorder |
| 2017-07-12 | Camurus AB | Results Camurus and Braeburn Pharmaceuticals Announce Topline Phase 2 Results for Long-acting Buprenorphine in Opioid Dependent Patients with Chronic Pain camurus.com ↗
The PK results confirmed the target weekly and monthly dosing intervals for the CAM2038 depots, showing extended buprenorphine release with dose dependent steady-state trough concentrations in the 2 to 3 ng/mL range. |
| 2017-07-12 | Braeburn Pharmaceuticals | Results Topline Phase 2 Results for Long-acting Buprenorphine in Opioid Dependent Patients with Chronic Pain braeburnrx.com ↗
Braeburn Pharmaceuticals and Camurus (NASDAQ STO: CAMX) today announced positive results from a Phase 2 pharmacokinetic study of weekly and monthly buprenorphine (CAM2038) depots in opioid dependent patients with moderate-to-severe non-cancer chronic pain. |
| 2017-06-22 | Camurus AB | Results Long-acting Buprenorphine Blocks Opioid Effects and Suppresses Withdrawal Symptoms in Adults with Opioid Use Disorder camurus.com ↗
Phase 2 clinical trial data demonstrate that long-acting buprenorphine (CAM2038), a novel subcutaneous buprenorphine depot formulation, produces an immediate and sustained blockade of opioid effects and suppression of withdrawal symptoms in adults with opioid use disorder. |
| 2017-06-22 | Braeburn Pharmaceuticals | Results Long-acting Buprenorphine Blocks Opioid Effects and Suppresses Withdrawal Symptoms braeburnrx.com ↗
Phase 2 clinical trial data demonstrate that long-acting buprenorphine (CAM2038), a novel subcutaneous buprenorphine depot formulation, produces an immediate and sustained blockade of opioid effects and suppression of withdrawal symptoms in adults with opioid use disorder. |
| 2017-06-21 | Indivior Inc. | Results Indivior | RBP-6000 Data Presented in Late-Breaking Research Oral Session at CPDD 79th Annual Scientific Meeting indivior.com ↗ |
| 2017-06-13 | Knight Therapeutics (USA) Inc | Regulatory Braeburn Pharmaceuticals and Knight Therapeutics Announce Filing of New Drug Submission for PROBUPHINE(R) in Canada for Opioid Drug Dependence knighttx.com ↗
Knight’s New Drug Submission (NDS) has been accepted for review by Health Canada for PROBUPHINE® (buprenorphine subdermal implant) |
| 2017-06-13 | Braeburn Pharmaceuticals | Regulatory Braeburn and Knight Therapeutics Announce Filing of PROBUPHINE® in Canada braeburnrx.com ↗
Knight’s New Drug Submission (NDS) has been accepted for review by Health Canada for Probuphine® (buprenorphine) implant for the treatment of opioid drug dependence. |
| 2017-05-30 | Indivior Inc. | Regulatory Indivior | Indivior Submits New Drug Application to U.S. FDA for RBP-6000 Buprenorphine Monthly Depot indivior.com ↗
This NDA submission includes the results from the pivotal Phase 3 study assessing the efficacy and safety of RBP-6000 which met both the primary and secondary endpoints. |
| 2017-05-02 | Camurus AB | Results Camurus and Braeburn Pharmaceuticals Announce Positive Top-line Results from Long-term Phase 3 Safety Study of CAM2038 camurus.com ↗
Lund, Sweden and Princeton, New Jersey — 2 May 2017 — Camurus (NASDAQ STO: CAMX) and Braeburn Pharmaceuticals today announced positive top-line results from a long-term Phase 3 trial supporting the safety and efficacy of CAM2038 (weekly and monthly buprenorphine depots) in patients with moderate-to-severe opioid use disorder. |
| 2017-05-02 | Braeburn Pharmaceuticals | Results Braeburn and Camurus Announce Positive Top-line Results from CAM2038 Safety Study braeburnrx.com ↗
Braeburn Pharmaceuticals and Camurus (NASDAQ STO: CAMX) today announced positive top-line results from a long-term Phase 3 trial supporting the safety and efficacy of CAM2038 (weekly and monthly buprenorphine depots) in patients with moderate-to-severe opioid use disorder. |
| 2017-03-28 | Indivior Inc. | Results Indivior | RBP-6000 Phase 3 PK/PD/RO and HEOR Subanalyses indivior.com ↗
Indivior PLC (LON: INDV) today announced additional subanalysis results from Phase 2 (RB-US-12-0005) and Phase 3 (RB-US-13-0001) studies that combined more than 17,000 observations from 507 subjects. |
| 2016-11-14 | Camurus AB | Results Braeburn Pharmaceuticals and Camurus Announce Positive Top-line Phase 3 Results for Long-acting Buprenorphine for Treatment of Opioid Addiction camurus.com ↗
Braeburn Pharmaceuticals and Camurus (NASDAQ STO: CAMX) are pleased to announce positive top-line results from a pivotal Phase 3 randomized, double-blind, double-dummy, active controlled trial of weekly and monthly injections of buprenorphine (CAM2038) for treatment of moderate-to-severe opioid use disorder. |
| 2016-10-04 | Orexo AB | Regulatory Mundipharma and Orexo announce EU regulatory submission for Zubsolv® orexo.com ↗
Mundipharma and Orexo make first EU regulatory submission for Zubsolv ® (buprenorphine and naloxone) sublingual tablet. |
| 2016-09-20 | Lannett Company, Inc. | Regulatory Lannett Announces Approval For Buprenorphine And Naloxone Sublingual Tablets, 2 mg/0.5 mg And 8 mg/2 mg investorroom.com ↗
Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, the therapeutic equivalent to the reference listed drug, Suboxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg. |
| 2016-09-02 | Orexo AB | Results Orexo completes 1,080 patient REZOLV study and reports on improved treatment of opioid dependent patients orexo.com ↗
From the patients evaluable for treatment, 77.6 percent (n=759) were determined to have been a treatment success, defined as a patient who completed 28 days of treatment and tested negative for opiates on the last follow-up drug screen. |
| 2016-08-17 | Indivior Inc. | Results Indivior | RBP-6000 Phase 3 Top Line Results indivior.com ↗
Indivior PLC (LON: INDV) today announces positive top-line results of the pivotal Phase 3 clinical trial of RBP-6000 buprenorphine monthly depot, an investigational new drug for the treatment of opioid use disorder as part of a complete treatment plan to include counseling and psychosocial support. |
| 2016-06-15 | Titan Pharmaceuticals | Results Titan Pharmaceuticals Announces Rigorous Sensitivity Analyses Confirm Effectiveness of Probuphine(R) for Opioid Dependence titanpharm.com ↗ |
| 2016-05-26 | Titan Pharmaceuticals | Regulatory Titan Pharmaceuticals Announces FDA Approval of Probuphine(R) for the Treatment of Opioid Dependence titanpharm.com ↗
Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) today announced that the U.S. Food and Drug Administration has approved Probuphine® (buprenorphine) implant, the first product for the long-term maintenance treatment of opioid dependence in clinically stable patients on 8 mg or less a day of oral buprenorphine. |
| 2016-05-26 | Indivior Inc. | Regulatory Indivior | Indivior Receives FDA Fast Track Designation for RBP-6000 Buprenorphine Monthly Depot for the Treatment of Opioid Use Disorder indivior.com ↗
Indivior Inc., a subsidiary of Indivior PLC (LON: INDV), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for RBP-6000 buprenorphine monthly depot, an investigational new drug for the treatment of opioid use disorder as part of a complete treatment plan to include counseling and psychosocial support. |
| 2016-05-11 | Camurus AB | Results Braeburn Pharmaceuticals and Camurus announce positive results from Phase 2 opioid challenge study with CAM2038 in subjects with opioid use disorder camurus.com ↗
The primary endpoint was met for both CAM2038 doses, demonstrating blockade of the subjective effects of hydromorphone as measured by the Drug-Liking Visual Analog Scale. |
| 2016-04-28 | Indivior Inc. | Results Indivior | Result of Phase 1 trial of RBP-6300 Buprenorphine Hemiadipate indivior.com ↗
The drug did not achieve the anticipated PK profile in humans to justify proceeding further with this technology. |
| 2016-04-15 | Titan Pharmaceuticals | Results Titan Pharmaceuticals Announces Presentation of Probuphine Phase 3 Data at American Society of Addiction Medicine Annual Conference titanpharm.com ↗
The study results show that participants in the implant group sustained clinical stability over the course of six months. |
| 2016-02-19 | Titan Pharmaceuticals | Regulatory Titan Pharmaceuticals Announces Notification of FDA Action Date Extension for Probuphine titanpharm.com ↗
The FDA has extended the date for agency action by the standard period, from Feb. 27, 2016 to May 27, 2016. |
| 2016-02-10 | Indivior Inc. | Regulatory Indivior | Indivior Inc. Receives a Paragraph IV Notice of Certification Letter (‘PIV Notice’) from Teva Pharmaceuticals USA, Inc. indivior.com ↗
Teva is already amongst the six ANDA filers to serve a PIV Notice on Indivior regarding Suboxone® sublingual film; this latest notice adds a new dosage strength to the range in its previous PIV notice. |
| 2016-01-12 | Titan Pharmaceuticals | Regulatory Titan Pharmaceuticals and Braeburn Pharmaceuticals Announce FDA Advisory Committee Recommends Approval of Probuphine, First 6-Month Implant to Treat Opioid Addiction titanpharm.com ↗ |
| 2015-12-10 | Relmada Therapeutics, Inc. | Results Relmada Therapeutics Announces Additional Information Regarding Positive Topline Results for Proof-of-Concept Study with BuTab relmada.com ↗ |
| 2015-12-09 | Titan Pharmaceuticals | Regulatory Titan Pharmaceuticals and Braeburn Pharmaceuticals Announce Date of FDA Advisory Committee Review of Probuphine for Opioid Addiction titanpharm.com ↗
Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) and partner Braeburn Pharmaceuticals today announced that the U.S. Food and Drug Administration has scheduled a meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) on Jan. 12, 2016 to review the New Drug Application (NDA) for Probuphine® for the maintenance treatment of opioid addiction. |
| 2015-11-04 | Camurus AB | Regulatory FDA grants Fast Track designation for development of CAM2038, long-acting buprenorphine injections to treat opioid addiction camurus.com ↗
Granting fast track to the CAM2038 development program demonstrates the FDA’s recognition of the unmet need in this area as well as the agency’s leadership in enabling new opportunities to stem the tide of opioid addiction. |
| 2015-09-28 | Titan Pharmaceuticals | Regulatory Titan Pharmaceuticals Announces FDA's Acceptance of Resubmission of New Drug Application for Probuphine titanpharm.com ↗
Titan Pharmaceuticals, Inc. (OTCQB: TTNP) announced today that the U.S. Food and Drug Administration has accepted for review the New Drug Application (NDA) for Probuphine®, a six-month subdermal implant containing buprenorphine hydrochloride for the long-term maintenance treatment of opioid addiction. |
| 2015-09-18 | Orexo AB | Regulatory New regulations will expand access to treatment of opioid dependence in the US orexo.com ↗
A key action mentioned by HHS includes revising the regulations related to buprenorphine to safely and effectively increase patient access. |
| 2015-08-31 | Titan Pharmaceuticals | Regulatory Titan Pharmaceuticals Announces Resubmission of the New Drug Application for Probuphine for the Maintenance Treatment of Opioid Addiction titanpharm.com ↗ |
| 2015-06-10 | Titan Pharmaceuticals | Results Titan Pharmaceuticals to Present at the BIO International Convention titanpharm.com ↗
The trial met all primary and secondary efficacy endpoints and plans are under way for the resubmission of the New Drug Application (NDA) later this year. |
| 2015-06-08 | Titan Pharmaceuticals | Results Titan Pharmaceuticals Reports Positive Results From Phase 3 Study of Probuphine for Opioid Addiction titanpharm.com ↗
Titan Pharmaceuticals, Inc. (OTCQB: TTNP) today reported positive topline results from the Phase 3 double blind, double dummy clinical study of Probuphine®, the company's subdermal implant containing buprenorphine HCl for the long-term maintenance treatment of opioid addiction. |
| 2014-06-25 | Orexo AB | Results Top-line data from a Phase 3 clinical trial demonstrates that Zubsolv® is as effective as Suboxone® film in the treatment of opioid dependence orexo.com ↗
Orexo announces top-line data from a Phase 3 clinical trial demonstrating that Zubsolv® (buprenorphine/naloxone CIII sublingual tablet) is as effective as Suboxone® film in the treatment of opioid dependence. |
| 2014-06-23 | Orexo AB | Results Positive Top-line Results from Two Phase 3 Clinical Trials that Assessed Zubsolv® for Induction of Buprenorphine Maintenance Therapy orexo.com ↗
Orexo AB (publ) announces the results of two clinical trials assessing Zubsolv for induction of buprenorphine maintenance therapy in patients with opioid dependence. |
| 2013-08-13 | Titan Pharmaceuticals | Results Titan Pharmaceuticals Announces Publication of Phase 3 Probuphine Data in Addiction titanpharm.com ↗
Probuphine results were statistically significant for the trial's protocol defined primary endpoint based on the percentages of urine samples that were negative for illicit opioid use, and incorporating patient self-reported opioid use over the 24-week treatment period (p < 0.0001) |
| 2013-05-01 | Titan Pharmaceuticals | Regulatory Titan Pharmaceuticals Receives Complete Response Letter From the FDA for Probuphine New Drug Application titanpharm.com ↗
The CRL states that the FDA cannot approve the application in its present form. |
| 2013-03-21 | Titan Pharmaceuticals | Regulatory Titan Pharmaceuticals Announces FDA Advisory Committee Recommends Approval of Probuphine for the Treatment of Adult Patients With Opioid Dependence titanpharm.com ↗ |
| 2013-01-02 | Titan Pharmaceuticals | Regulatory Probuphine(R) Receives FDA Priority Review Designation for Adult Patients With Opioid Dependence titanpharm.com ↗
Titan Pharmaceuticals, Inc. (OTCBB: TTNP) today announced that the New Drug Application (NDA) for Probuphine® has been accepted for review and granted Priority Review designation by the U.S. Food and Drug Administration (FDA). |
| 2012-11-28 | Orexo AB | Results New study by Orexo emphasizes importance of Zubsolv™ product characteristics in direct comparison to Suboxone® Film orexo.com ↗
The study shows that 9 out of 10 participants would choose Zubsolv over Suboxone Film for a daily treatment. |
| 2012-11-19 | Orexo AB | Regulatory Orexo announces that Zubsolv™ has been accepted for review by the U.S. Food and Drug Administration (FDA) orexo.com ↗
FDA has informed Orexo that the Zubsolv New Drug Application (NDA) has been accepted for review, and that the Prescription Drug User Fee Act (PDUFA) action date will be July 6, 2013. |
| 2012-09-06 | Orexo AB | Regulatory Swedish specialty pharmaceutical company Orexo announced today the submission of a New Drug Application for Zubsolv™ (OX219) to the US FDA orexo.com ↗
Orexo is the first company to submit a New Drug Application (NDA) for a novel combination product of buprenorphine and naloxone for treatment of opioid dependence, a condition affecting over two million Americans. |
| 2012-07-02 | Orexo AB | Results Orexo takes large step forward on the road to improve treatment for people dependent on opioid pain killers orexo.com ↗
In the study, OX219 was tested against brand leader Suboxone®, where it demonstrated both comparative bioavailability for the two active ingredients as well as positive results for product attributes which are important from the patient’s perspective. |
| 2012-06-19 | Orexo AB | Results Orexo successfully completes OX219 dose proportionality study ahead of schedule orexo.com ↗
The results of the study are in line with the projected dose proportionality and comparable to what has been observed in studies of other buprenorphine products. |
| 2012-02-09 | Titan Pharmaceuticals | Results Titan Pharmaceuticals Announces Positive Results of Six-Month Open-Label Safety Retreatment Study of Probuphine titanpharm.com ↗
Patients also reported a decreased use of illicit opioids, good control of opioid withdrawal and cravings and high overall satisfaction with Probuphine. |
| 2011-08-16 | Titan Pharmaceuticals | Results Titan Pharmaceuticals Announces Second Quarter 2011 Financial Results titanpharm.com ↗ |
| 2011-08-16 | Titan Pharmaceuticals | Results Titan Pharmaceuticals Provides Additional Positive Results in Confirmatory Phase 3 Trial of Probuphine titanpharm.com ↗
Probuphine was found to be well tolerated and Probuphine treatment resulted in a significant improvement in the global severity of opioid dependence (p = 0.0003) and overall patient improvement (p = 0.0002) versus placebo, as assessed by clinicians. |
| 2011-07-11 | Titan Pharmaceuticals | Results Titan Pharmaceuticals Announces Positive Top Line Results in Confirmatory Phase 3 Trial of Probuphine titanpharm.com ↗
Titan Pharmaceuticals, Inc. (OTCBB: TTNP) today announced positive results from its Phase 3 placebo- and active drug-controlled confirmatory clinical study of Probuphine™, evaluating the safety and efficacy of its investigational drug in treating patients with opioid dependence. |
| 2011-06-27 | Alkermes, Inc. | Results Pharmacoeconomic Value of Addiction Treatments, Including VIVITROL®, Published in Leading Healthcare Policy Journal alkermes.com ↗
In addition, despite higher pharmacy costs for VIVITROL, the total healthcare costs for VIVITROL were no greater than buprenorphine or oral naltrexone, and were 49% lower than methadone. |
| 2010-11-17 | Titan Pharmaceuticals | Results Titan Pharmaceuticals Presents Phase 3 Probuphine™ Data at Society for Neuroscience Annual Meeting titanpharm.com ↗
The presentation, "Development of an Implantable Formulation of Buprenorphine for Opioid Addiction," was delivered by Katherine Beebe , Ph.D., senior vice president, clinical development and medical affairs at Titan and outlined the positive data demonstrated by Probuphine in Phase 3 clinical trials conducted to date in patients with opioid addiction. |
| 2010-10-25 | Alkermes, Inc. | Results Alkermes Announces Positive Results from Phase 1 Study of ALKS 33 in Combination with Buprenorphine for Treatment of Cocaine Addiction alkermes.com ↗
Data from the study showed that the combination therapy was generally well tolerated and sublingual administration of ALKS 33 effectively blocked the agonist effects of buprenorphine. |
| 2010-10-12 | Titan Pharmaceuticals | Results Titan Pharmaceuticals Announces Journal of the American Medical Association Publication of Phase 3 Probuphine™ Data titanpharm.com ↗ |
All press releases naming this drug 301 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 301 releases opens the full record — a long page | ||
Evidence & citations 47 cited values
Every value below carries the sentence it was read from. 409 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | buprenorphine | “In collaboration with the National Institute on Drug Abuse (NIDA), Alkermes, Inc. is investigating a fixed-dose combination product consisting of ALKS 33 (also referred to as...” NCT01366001 ↗382“Individuals will receive extended-release buprenorphine, administered as a subcutaneous injection, is available in seven different dosage strengths for weekly (8, 16, 24, and...” NCT04408313 ↗ “OBJECTIVE: To evaluate the ability of a novel, weekly, subcutaneous buprenorphine depot formulation, CAM2038, to block euphorigenic opioid effects and suppress opioid...” PMID 28655025 ↗ Sep 2017 “SUBLOCADE (buprenorphine extended-release) injection is a colorless to amber sterile solution for SC injection designed to deliver buprenorphine at doses of 100 mg or 300 mg at...” NCT03818399 ↗ “SUBLOCADE (buprenorphine extended-release) injection is a colorless to amber sterile solution for SC injection designed to deliver buprenorphine at doses of 100 mg or 300 mg at...” NCT04523792 ↗ “Sublocade and Brixadi, two distinct, branded, formulations of extended-release buprenorphine (XR-B), offer a promising approach to improving MOUD treatment adherence and...” PMID 40645369 ↗ Jul 2025 “The purpose of this study is to assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in healthy,...” NCT00000331 ↗ “CAM2038 subcutaneous (SC) buprenorphine (BPN) extended-release injections compared to daily sublingual (SL) BPN/naloxone (BPN/NX) tablets, and equivalent placebos, in OUD...” PMID 39629836 ↗ Dec 2024 “The purpose of this study is to determine if the opioid agonist effects of doses of 4/1 mg, 8/2 mg, and 16/4 mg of buprenorphine/naloxone can be completely blocked by 50 mg of...” NCT00733720 ↗ “A single Suboxone sublingual film strip containing 8mg buprenorphine and 2mg naloxone taken sublingually on either Day 0 or Day 1, depending on randomized treatment arm assignment.” NCT02038790 ↗ “Buprenorphine is a partial μ-opioid receptor agonist that, unlike full μ-opioid receptor agonists, has been shown to have a ceiling effect on respiratory depression.” PMID 32978722 ↗ Sep 2020 |
| Known as | Belbuca | “Day 1: participants will receive buprenorphine (Belbuca) 225 mcg mg every 12 hours” NCT05118204 ↗1“Buprenorphine 0.15 MG [Belbuca]” NCT05778591 ↗ |
| Known as | BEMA Buprenorphine | “BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa.” NCT01298765 ↗1“BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa.” NCT01431742 ↗ |
| Known as | BNP | “Buprenorphine (BNP) has gained widespread use in the treatment of adult opioid dependence.” NCT02249026 ↗ |
| Known as | BPN | “The primary objective of the study is to demonstrate maintenance of treatment efficacy when transferring adult outpatients with opioid dependence, who are clinically stabilized...” NCT02180659 ↗3“Buprenorphine (BPN) combined with Valproate (VPA) - will result in fewer withdrawal symptoms during detoxification of opiate-polydrug users than the existing treatment regimen,...” NCT00367874 ↗ “Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in...” NCT00630201 ↗ “AIMS: To provide controlled data on direct induction with buprenorphine/naloxone (BNX) versus indirect buprenorphine (BPN)-to-BNX induction.” PMID 21749526 ↗ Oct 2011 |
| Known as | Brixadi | “This study is an open label pilot study of 30 incarcerated men and women receiving sublingual buprenorphine (SL-B) in jail who will voluntarily switch to extended-release...” NCT07524738 ↗3“Sublocade and Brixadi, two distinct, branded, formulations of extended-release buprenorphine (XR-B), offer a promising approach to improving MOUD treatment adherence and...” PMID 40645369 ↗ Jul 2025 “This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail.” NCT06306443 ↗ |
| Known as | BSL | “sublingual buprenorphine (BSL)” NCT04352166 ↗ |
| Known as | BTDS | “The primary objective of this study is to evaluate the efficacy and safety of buprenorphine transdermal system (BTDS) compared to placebo in subjects with moderate to severe...” NCT00345787 ↗7“OBJECTIVES: The aim of this noninferiority study was to investigate clinical effectiveness and safety of buprenorphine transdermal system (BTDS) in patients with moderate to...” PMID 25503600 ↗ Jul 2015 “Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Mod to...” NCT01141283 ↗ “The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery;” NCT00403234 ↗ “A Double-Blind Comparative Study of Buprenorphine Transdermal System (BTDS) and Hydrocodone/Acetaminophen Tablets in Patients With Chronic Back Pain” NCT00315887 ↗ “Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Low Back Pain” NCT00346047 ↗ “Buprenorphine transdermal (BTDs) is a semi-synthetic opioid analgesic.” NCT02519387 ↗ “buprenorphine transdermal delivery system (BTDS), brand name Butrans.” NCT02138357 ↗ |
| Known as | BUP | “HIV-seronegative subjects stabilized on at least 3 weeks of buprenorphine/naloxone (BUP/NLX) therapy sequentially underwent baseline and steady-state pharmacokinetic evaluation” PMID 19726139 ↗ Sep 200910“Buprenorphine (BUP) is a partial opiate agonist dosed sublingually for both supervised opiate withdrawal and maintenance for opiate dependence.” NCT00571961 ↗ “Treatment-as-usual (TAU) is standard dosing of buprenorphine (BUP) to a median dose of 24 mg (range 16-32 mg).” NCT04850664 ↗ “Buprenorphine (BUP) stabilization up to 12 mg (day 2 of week 1) then a 10-day BUP taper by the end of week 3.” NCT02543944 ↗ “12mg of buprenorphine (BUP) split as 8mg at 0 minutes and 4mg at time 30-60 min as an induction dose” NCT05589181 ↗ “sublingual BUP (as Suboxone®) in the presence of extended-release injectable naltrexone” PMID 23159524 ↗ Nov 2012 “low-dose oral naltrexone (NTX), combined with a brief buprenorphine (BUP) taper” PMID 29674251 ↗ Apr 2018 “12-16 mg of transmucosal (TM) BUP (SUBOXONE®)” NCT06576843 ↗ “buprenorphine (BUP) discontinuation” NCT03232346 ↗ “Drug: Buprenorphine (BUP)” NCT06323824 ↗ “Buprenorphine (BUP)” NCT02360007 ↗ |
| Known as | BUP-Inj | “Buprenorphine injection (BUP-Inj)” NCT05283304 ↗ |
| Known as | BUP-XR | “Buprenorphine extended-release monthly formulation (BUP-XR, SUBLOCADE®) is approved for treatment of moderate-to-severe opioid use disorder (OUD) following subcutaneous...” PMID 39543001 ↗ Nov 20241“Subcutaneously injected, extended-release buprenorphine (BUP-XR) may be more effective-but there has been no superiority evaluation.” PMID 38045803 ↗ Nov 2023 |
| Known as | Buprenex | “one IM injection of 0.3mg/1ML buprenorphine hydrochloride (Buprenex®. Richmond, VA: Reckitt Benckiser Pharmaceuticals Inc.; 2006)” NCT04276259 ↗1“Buprenex (buprenorphine) 2mg sublingual (SL) (taken every day for 12 weeks)” NCT03852628 ↗ |
| Known as | Buprenex (buprenorphine) | “Buprenex (buprenorphine)” NCT00521248 ↗ |
| Known as | Buprenorphine and naloxone sublingual film | “Buprenorphine and naloxone sublingual film” NCT02477267 ↗ |
| Known as | buprenorphine buccal film | “A Phase I Placebo-Controlled Trial Comparing the Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride Administration on Respiratory Drive.” PMID 32978722 ↗ Sep 2020 |
| Known as | buprenorphine HCl | “Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.” NCT00772785 ↗ |
| Known as | buprenorphine hydrochloride | “Participants were randomized to receive sublingual buprenorphine plus 4 placebo implants or sublingual placebo plus four 80-mg buprenorphine hydrochloride implants (expected...” PMID 27434441 ↗ Jul 20166“Subutex (buprenorphine hydrochloride) and Suboxone tablets (buprenorphine hydrochloride and naloxone hydrochloride) are approved for the treatment of opiate dependence.” NCT01560221 ↗ “BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa.” NCT01298765 ↗ “BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa.” NCT01431742 ↗ “one IM injection of 0.3mg/1ML buprenorphine hydrochloride (Buprenex®. Richmond, VA: Reckitt Benckiser Pharmaceuticals Inc.; 2006)” NCT04276259 ↗ “Subutex, Buprenorphine Hydrochloride, SCH 28444” NCT00605033 ↗ |
| Known as | Buprenorphine Transdermal System | “Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Mod to...” NCT01141283 ↗3“A Double-Blind Comparative Study of Buprenorphine Transdermal System (BTDS) and Hydrocodone/Acetaminophen Tablets in Patients With Chronic Back Pain” NCT00315887 ↗ “Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Low Back Pain” NCT00346047 ↗ “Buprenorphine Transdermal System 5, 10 or 20mg/patch is applied for 12weeks” NCT00345787 ↗ |
| Known as | Buprenorphine transdermal system (BTDS) | “Buprenorphine transdermal system (BTDS)” NCT01019265 ↗ |
| Known as | Butrans | “hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™)” NCT00312572 ↗ |
| Known as | BXR | “The monthly Sublocade buprenorphine extended-release (BXR) injection will be administered in two doses (100 mg and 300 mg).” NCT03861338 ↗1“extended-release buprenorphine (BXR)” NCT04352166 ↗ |
| Known as | CAM2038 | “OBJECTIVE: To evaluate the ability of a novel, weekly, subcutaneous buprenorphine depot formulation, CAM2038, to block euphorigenic opioid effects and suppress opioid...” PMID 28655025 ↗ Sep 20173“CAM2038 subcutaneous (SC) buprenorphine (BPN) extended-release injections compared to daily sublingual (SL) BPN/naloxone (BPN/NX) tablets, and equivalent placebos, in OUD...” PMID 39629836 ↗ Dec 2024 “Long-term safety of a weekly and monthly subcutaneous buprenorphine depot (CAM2038) in the treatment of adult out-patients with opioid use disorder.” PMID 31013390 ↗ Jun 2019 “The XR-BUP condition will use Brixadi®/CAM2038 injectable, extended-release buprenorphine.” NCT06023459 ↗ |
| Known as | Extended Release Buprenorphine | “This is a clinical trial to characterize the safety and pharmacokinetics of using extended-release buprenorphine (XR-BUP) as a novel low-dose buprenorphine induction strategy.” NCT06441604 ↗1“Extended-Release buprenorphine (XR-BUP) two doses of 300mg XR-BUP (Weeks 0, 4) via subcutaneous injections in the abdomen.” NCT05262270 ↗ |
| Known as | extended-release buprenorphine (XR-B) "sublocade" | “extended-release buprenorphine (XR-B) "sublocade"” NCT05991622 ↗ |
| Known as | INDV-6200 | “INDV-6200 is a novel buprenorphine subcutaneous (SC) depot formulation being developed for the treatment of opioid dependency.” NCT03715634 ↗ |
| Known as | Nopan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01046851 ↗ |
| Known as | Norspan | “A Multicenter, Phase IV, Interventional Study to Assess the Efficacy and Safety of NORSPAN® (Buprenorphine) in Korean Patients With Spinal Disorders (NOBLE)” NCT01818700 ↗1“NORSPAN Buprenorphine Transdermal Patchs for Lower dose group” NCT06772324 ↗ |
| Known as | Other Name: Buprenex (buprenorphine) | “Other Name: Buprenex (buprenorphine)” NCT01708707 ↗ |
| Known as | Probuphine | “Buprenorphine (BPN) is an approved treatment for opioid dependence, however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in...” NCT00447564 ↗5“Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN).” NCT01114308 ↗ “Probuphine (buprenorphine implant) is an implant placed just beneath the skin that contains BPN.” NCT00772785 ↗ “Probuphine (buprenorphine implant)” NCT00630201 ↗ “Probuphine (buprenorphine implant)” NCT00768482 ↗ |
| Known as | SCH 28444 | “Subutex, Buprenorphine Hydrochloride, SCH 28444” NCT00605033 ↗ |
| Known as | SLB | “This study is an open label pilot study of 30 incarcerated men and women receiving sublingual buprenorphine (SL-B) in jail who will voluntarily switch to extended-release...” NCT07524738 ↗1“Sublingual Buprenorphine (SLB)” NCT06051890 ↗ |
| Known as | Sublocade | “SUBLOCADE (buprenorphine extended-release) injection is a colorless to amber sterile solution for SC injection designed to deliver buprenorphine at doses of 100 mg or 300 mg at...” NCT03818399 ↗7“SUBLOCADE (buprenorphine extended-release) injection is a colorless to amber sterile solution for SC injection designed to deliver buprenorphine at doses of 100 mg or 300 mg at...” NCT04523792 ↗ “Sublocade and Brixadi, two distinct, branded, formulations of extended-release buprenorphine (XR-B), offer a promising approach to improving MOUD treatment adherence and...” PMID 40645369 ↗ Jul 2025 “The monthly Sublocade buprenorphine extended-release (BXR) injection will be administered in two doses (100 mg and 300 mg).” NCT03861338 ↗ |
| Known as | Suboxone | “Drug: buprenorphine (Suboxone)” NCT01082679 ↗ |
| Known as | Subutex | “Subutex (buprenorphine hydrochloride) and Suboxone tablets (buprenorphine hydrochloride and naloxone hydrochloride) are approved for the treatment of opiate dependence.” NCT01560221 ↗4“This study seeks to improve the treatment of chronic pain in people who are taking buprenorphine (also known as Suboxone, Subutex, Zubsolv).” NCT06367387 ↗ “Subutex, Buprenorphine Hydrochloride, SCH 28444” NCT00605033 ↗ “Buprenorphine/Subutex” NCT00383045 ↗ |
| Known as | Subutex (buprenorphine sublingual tablets) | “Subutex (buprenorphine sublingual tablets)” NCT00750217 ↗ |
| Known as | T2rev | “new buprenorphine transdermal patch T2rev formulation containing 13 mg buprenorphine (Test) as compared to Transtec(R) PRO 70 µg/h patch transdermal patch containing 40 mg...” NCT00387777 ↗ |
| Known as | Temgesic | “Investigators will administer placebo, 0.2 mg buprenorphine (Temgesic) via sublingual tablet in counterbalanced order under double-blind conditions.” NCT02659787 ↗ |
| Known as | Transtec | “Transtec (Registered Trademark) transdermal patch containing 20 milligrams buprenorphine in an active surface area of 25 square centimeters, release rate 35 micrograms per hour.” NCT03785613 ↗1“application of the Transtec (Registered Trademark) patch” NCT03770234 ↗ |
| Known as | Transtec (buprenorphine patch) | “Transtec (buprenorphine patch)” NCT00750217 ↗ |
| Known as | Transtec (R) PRO | “Transtec (R) PRO (buprenorphine)” NCT00388219 ↗ |
| Known as | XR-B | “County jails willing to provide extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-B) will participate in a randomized controlled trial throughout the...” NCT04408313 ↗4“This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail.” NCT06306443 ↗ “Participants will initiate extended-release buprenorphine (XR-B) treatment at the time of admission.” NCT05481112 ↗ “Extended-release buprenorphine (XRB) offers a novel approach to sustained monthly treatment” PMID 35093164 ↗ Jan 2022 “Extended-Release Buprenorphine (XRB)” NCT06051890 ↗ |
| Known as | XR-BUP | “This protocol describes an open-label randomized comparative effectiveness trial comparing ACS treatment as usual (TAU) to a single injection of a 28-day formulation...” PMID 39623502 ↗ Dec 20242“The study is a single-blind, fixed-order, dose-escalation designed trial in an inpatient setting with individuals with a DSM-5 diagnosis of OUD (n=30). The first 10...” NCT06441604 ↗ |
| Known as | XR-BUP (Brixadi) | “XR-BUP (Brixadi)” NCT06023459 ↗ |
| Known as | Zubsolv | “Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)” NCT07469501 ↗ |
| Action | Activate | “Buprenorphine, a partial mu-opioid agonist, is an alternative treatment for opioid dependence but has not been extensively studied in pregnancy.” PMID 21142534 ↗ Dec 2010 |
| Modality | Other / unclassified | “mixed opioid agonist-antagonist buprenorphine” NCT00863291 ↗ |
| Route | Intravenous | “intravenous buprenorphine” NCT00000331 ↗ |