Drugs / Sufentanil
Sufentanil
also known as
Sufentanyl · Sufentanil Citrate · ARX-F01 · Dsuvia · Sufentanil Injection · Sufentanil NanoTab · Brand name:Sufenta · Dzuveo · +14 more
Other / unclassified targets OPRM1 via activation
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | DSUVIA | acute pain | 2017-10-12 | “received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration ( FDA ) regarding its New Drug Application (NDA) for DSUVIA” talphera.com ↗ |
| Filed | US (FDA) | DSUVIA | acute pain | 2017-02-27 | “announced today the U.S. Food and Drug Administration ( FDA ) has accepted the company's New Drug Application (NDA) under section 505(b)(2) for DSUVIA™” talphera.com ↗ “DSUVIA NDA Accepted and PDUFA Date Set for October 12, 2017” talphera.com ↗ |
| Approved | EU (EMA) | Zalviso | — | 2015-09-18 | europa.eu ↗ |
| Filed | US (FDA) | Zalviso | acute pain | 2013-09-30 | “today announced that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for Zalviso™ (sufentanil sublingual microtablet system).” talphera.com ↗ |
| Label expansion | US (FDA) | SUFENTA PRESERVATIVE FREE | — | 1993-03-19 | fda.gov ↗ |
| Approved | US (FDA) | SUFENTA PRESERVATIVE FREE | — | 1984-05-04 | fda.gov ↗ |
| Filed | EU (EMA) | ARX-04 | acute pain | — | “In the EU, the European Medicines Agency (EMA) has notified the Company that the ARX-04 (sufentanil sublingual tablet, 30 mcg) Marketing Authorisation Application (MAA) has...” talphera.com ↗ “In the EU, the European Medicines Agency (EMA) has notified the company that the ARX-04 Marketing Authorization Application (MAA) is under scientific review.” talphera.com ↗ “In the EU, the European Medicines Agency (EMA) has notified the company that the DZUVEO Marketing Authorization Application (MAA) is under scientific review.” talphera.com ↗ “The MAA for ARX-04 (known as DSUVIA™ in the U.S.) was filed in early March 2017” talphera.com ↗ |
Trials 113 · started per year
today
US approved 1984
EU approved 2015
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT07603596 | May 2026 → Apr 2028 expected | delirium, digestive system neoplasm | Qianfoshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT02082236 | May 2014 | — | Talphera, Inc | Completed | No outcome recorded |
| Phase 1 | NCT01761565 | Jan → Feb 2013 | — | Talphera, Inc | Completed | No outcome recorded |
| Phase 1 | NCT01721070 | Nov → Dec 2012 | — | Talphera, Inc | Completed | No outcome recorded |
| Phase 1 | NCT01639729 | Jul 2012 | — | Talphera, Inc | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04959812 | Mar 2022 → Sep 2023 | — | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT01012999 | Nov 2009 → Mar 2011 | — | University of Utah | Terminated | No outcome recorded Stop: Enrollment |
| Phase 211 trials · 4 met primary | ||||||
| Phase 2 | NCT06968546 | Feb 2026 → Mar 2028 expected | disease of bone structure | Fondation Lenval | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04897750 | Aug 2021 → May 2022 | pain agnosia | Cessatech A/S | Completed | No outcome recorded |
| Phase 2 | NCT02962830 | Apr 2017 → May 2024 | — | University Hospital, Lille | Completed | No outcome recorded |
| Phase 2 | NCT01710345 | Oct 2012 → Feb 2013 | — | Talphera, Inc | Completed | Met primary |
| Phase 2 | NCT01047241 | Apr 2010 → Feb 2013 | — | Danish University of Pharmaceutical Sciences | Completed | No outcome recorded |
| Phase 2 | NCT00943566 | Jan → Dec 2010 | chronic pain syndrome | Labtec GmbH | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT00833040 | Apr 2009 → Mar 2010 | cancer | Talphera, Inc | Completed | Met primary |
| Phase 2 | NCT00859313 | Apr → Aug 2009 | neuropathy, painful | Talphera, Inc | Completed | No outcome recorded |
| Phase 2 | NCT00718081 | Aug 2008 → Mar 2009 | — | Talphera, Inc | Completed | Met primary |
| Phase 2 | NCT00612534 | Mar → Oct 2008 | — | Talphera, Inc | Completed | Met primary |
| Phase 2 | NCT02430090 | Nov 2006 → Mar 2007 | — | Ankara City Hospital Bilkent | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06364072 | May 2024 → May 2025 | — | Cessatech A/S | Completed | No outcome recorded |
| Phase 2/3 | NCT02334150 | Jun 2013 → Jun 2014 | dystocia | Nanjing Maternity and Child Health Care Hospital | Completed | No outcome recorded |
| Phase 321 trials · 5 met primary · 4 missed | ||||||
| Phase 3 | NCT06917651 | Apr 2025 → Apr 2027 expected | — | University Hospital, Clermont-Ferrand | Recruiting | No outcome recorded |
| Phase 3 | NCT06181695 | May 2024 → May 2026 overdue | sickle cell disease | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05288348 | Aug 2022 → Jan 2024 | — | Frank Guyette | Completed | Missed primary |
| Phase 3 | NCT05196256 | Jun 2022 → Jun 2023 | obstetric disorder | Brugmann University Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04076748 | Jul 2021 → Jul 2024 | sickle cell disease | University Hospital, Bordeaux | Terminated | No outcome recorded |
| Phase 3 | NCT03639389 | Jan 2019 → Mar 2022 | — | Karolinska Institutet | Completed | No outcome recorded |
| Phase 3 | NCT05576675 | May 2018 → Mar 2022 | — | Xijing Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02662764 | Sep 2016 → Apr 2017 | — | Talphera, Inc | Completed | Met primary |
| Phase 3 | NCT02662556 | Mar → Jun 2016 | — | Talphera, Inc | Completed | No outcome recorded |
| Phase 3 | NCT02447848 | Oct 2015 → Jun 2016 | — | Talphera, Inc | Completed | No outcome recorded |
| Phase 3 | NCT02356588 | Feb → Jun 2015 | — | Talphera, Inc | Completed | Met primary |
| Phase 3 | NCT02868944 | Aug 2014 → Jan 2017 | — | Reims University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02264834 | Jul 2014 → Mar 2018 | — | Dr Madeleine Wilwerth | Completed | No outcome recorded |
| Phase 3 | NCT01660763 | Aug 2012 → Apr 2013 | — | Talphera, Inc | Completed | Met primary |
| Phase 3 | NCT01539538 | Apr → Dec 2012 | — | Talphera, Inc | Completed | Met primary |
| Phase 3 | NCT01539642 | Feb 2012 → Jan 2013 | — | Talphera, Inc | Completed | Met primary |
| Phase 3 | NCT01367418 | Sep 2010 → Mar 2012 | prostate cancer | Örebro University, Sweden | Completed | No outcome recorded |
| Phase 3 | NCT01082744 | Mar 2010 → Sep 2014 | neuropathy, painful | Hospices Civils de Lyon | Completed | Missed primary |
| Phase 3 | NCT01025102 | Jan 2010 → Nov 2012 | — | Bent Gymoese Jorgensen | Completed | No outcome recorded |
| Phase 3 | NCT00656773 | Jan → Sep 2008 | — | University Hospital, Toulouse | Completed | Missed primary |
| Phase 3 | NCT00389883 | Nov 2006 → Jan 2010 | supratentorial cancer | Assistance Publique - Hôpitaux de Paris | Completed | Missed primary |
| Phase 429 trials · 3 met primary | ||||||
| Phase 4 | NCT07624006 | Jan 2027 → Feb 2030 expected | — | University Hospital, Strasbourg, France | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07597564 | Jun 2026 → May 2027 expected | — | Fujian Provincial Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07026162 | Jul 2025 → Feb 2026 | — | YanYing Xiao | Completed | No outcome recorded |
| Phase 4 | NCT06784999 | Jan 2025 → Nov 2027 expected | — | Indiana University | Recruiting | No outcome recorded |
| Phase 4 | NCT05957653 | Oct 2023 → Sep 2025 | prostate cancer | RenJi Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT06439368 | Jan 2023 → Dec 2024 | — | Yangtze River Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 4 | NCT04716413 | Sep 2021 → Nov 2022 | — | Montefiore Medical Center | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT04263909 | Dec 2020 → Apr 2022 | substance-related disorder | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04387136 | Oct 2020 → Feb 2021 | — | University of Minnesota | Completed | No outcome recorded |
| Phase 4 | NCT04226495 | Oct 2020 → Oct 2021 | — | University of Nebraska | Completed | No outcome recorded |
| Phase 4 | NCT04443946 | Jun → Aug 2020 | — | China International Neuroscience Institution | Completed | No outcome recorded |
| Phase 4 | NCT04432428 | May 2020 → Aug 2021 | — | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT04396587 | May 2020 → Jan 2023 | substance-related disorder | Peking University People's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04137198 | Jan 2020 → Jul 2025 | — | Centre Hospitalier Universitaire Saint Pierre | Unknown | Met primary |
| Phase 4 | NCT04177862 | Dec 2019 → Jan 2020 | — | University of Minnesota | Completed | No outcome recorded |
| Phase 4 | NCT04111328 | Oct 2019 → Sep 2020 | — | Jun Wang | Completed | Met primary |
| Phase 4 | NCT05259098 | Oct 2019 → Jun 2020 | chronic pain syndrome | Hospital Central do Funchal | Completed | No outcome recorded |
| Phase 4 | NCT03901716 | Jan → Mar 2019 | — | Guangzhou Institute of Respiratory Disease | Completed | No outcome recorded |
| Phase 4 | NCT03386630 | Mar 2018 → Jun 2019 | — | Fundación Pública Andaluza Progreso y Salud | Completed | No outcome recorded |
| Phase 4 | NCT03135795 | Feb → May 2017 | — | Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 4 | NCT03224039 | Jan 2017 → Jan 2019 | — | The Brooklyn Hospital Center | Unknown | No outcome recorded |
| Phase 4 | NCT02503826 | Jan → Dec 2015 | — | Second Affiliated Hospital of Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 4 | NCT02205580 | Sep → Dec 2014 | adenoid hypertrophy, sleep apnea syndrome, tonsillitis | Jin Ni | Unknown | No outcome recorded |
| Phase 4 | NCT01954368 | Jan 2014 → Mar 2016 | — | Centre Hospitalier Universitaire de Nice | Completed | No outcome recorded |
| Phase 4 | NCT02095366 | Aug 2013 → Apr 2016 | — | University Hospital, Grenoble | Completed | Met primary |
| Phase 4 | NCT01777100 | Jul 2012 → Oct 2014 | — | University of Sao Paulo | Completed | No outcome recorded |
| Phase 4 | NCT01356732 | Jan → Oct 2010 | — | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 4 | NCT00577200 | Jan 2008 → Nov 2026 expected | — | Rush University Medical Center | Active not recruiting | No outcome recorded |
| Phase 4 | NCT00421720 | Jan 2007 → ? | — | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase not applicable43 trials · 5 met primary · 1 missed | ||||||
| — | NCT07650812 | Jul 2026 → Dec 2027 expected | bowel dysfunction | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07651722 | Jun → Sep 2026 overdue | paralytic ileus | Tianjin First Central Hospital | Recruiting | No outcome recorded |
| — | NCT07089173 | Aug 2025 → Jul 2026 overdue | — | Peking University Shenzhen Hospital | Recruiting | No outcome recorded |
| — | NCT06990893 | Jun 2025 → Oct 2026 expected | — | Anqing Municipal Hospital | Recruiting | No outcome recorded |
| — | NCT07401641 | Jun 2025 → Jun 2026 overdue | oral cavity cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| — | NCT06808841 | Feb → May 2025 overdue | — | Second Hospital of Shanxi Medical University | Not yet recruiting | No outcome recorded |
| — | NCT06015165 | Sep 2024 → Jun 2025 overdue | — | China-Japan Friendship Hospital | Recruiting | No outcome recorded |
| — | NCT06414018 | May → Dec 2024 | — | Tongji Hospital | Completed | No outcome recorded |
| — | NCT06260046 | Mar 2024 → Jan 2025 overdue | — | Seoul National University Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06658990 | Feb → Jun 2024 | — | Northern Jiangsu People's Hospital | Completed | No outcome recorded |
| — | NCT06091904 | Nov 2023 → Nov 2025 overdue | — | Seoul National University Hospital | Recruiting | No outcome recorded |
| — | NCT05901389 | Jun → Dec 2023 | — | Qilu Hospital of Shandong University | Completed | No outcome recorded |
| — | NCT05863455 | May 2023 → Oct 2024 | — | Affiliated Hospital of Jiaxing University | Completed | Met primary |
| — | NCT05384665 | May → Oct 2023 | — | Centre Hospitalier Sud Francilien | Terminated | No outcome recorded |
| — | NCT05785234 | Apr 2023 → Mar 2025 | gastric neoplasm | Yonsei University | Unknown | No outcome recorded |
| — | NCT05672212 | Jan 2023 → Jan 2025 | — | Seoul National University Hospital | Unknown | Met primary |
| — | NCT05497492 | Nov 2022 → Dec 2023 | — | Beijing Friendship Hospital | Unknown | No outcome recorded |
| — | NCT06000137 | Feb 2022 → Jan 2023 | — | Eye & ENT Hospital of Fudan University | Completed | No outcome recorded |
| — | NCT04446715 | Oct 2020 → Aug 2021 | — | Makassed General Hospital | Unknown | Met primary |
| — | NCT04067648 | Jul 2020 → Dec 2022 | — | Tongji Hospital | Completed | No outcome recorded |
| — | NCT03868111 | Nov 2019 → Jan 2020 | — | Kangbuk Samsung Hospital | Completed | No outcome recorded |
| — | NCT04121416 | Apr → Aug 2019 | cardiovascular disorder | Shengjing Hospital | Completed | No outcome recorded |
| — | NCT03864016 | Mar → Oct 2019 | — | Centre Hospitalier Universitaire Dijon | Completed | Met primary |
| — | NCT03622047 | Aug 2018 → Aug 2020 | — | Fudan University | Unknown | No outcome recorded |
| — | NCT03598192 | Aug → Sep 2018 | liver disorder | Gia Dinh People Hospital | Completed | No outcome recorded |
| — | NCT03381495 | May → Sep 2018 | mental disorder | Deng Dongrui | Unknown | No outcome recorded |
| — | NCT04048070 | May → Oct 2018 | chronic rhinosinusitis | Beijing Tongren Hospital | Completed | No outcome recorded |
| — | NCT04448457 | Sep 2017 → Jul 2018 | — | Centre Hospitalier Universitaire de Tivoli | Completed | Missed primary |
| — | NCT03171610 | Jun 2017 → Jan 2018 | — | Yonsei University | Completed | No outcome recorded |
| — | NCT02920489 | Aug 2016 → Jun 2017 | — | Peking University First Hospital | Completed | No outcome recorded |
| — | NCT05596071 | Jun 2016 → Jul 2020 | delirium | Zhejiang Cancer Hospital | Completed | No outcome recorded |
| — | NCT02604797 | Jan 2016 → Jan 2017 | — | Fudan University | Unknown | No outcome recorded |
| — | NCT02595333 | Nov 2015 → Aug 2017 | — | Fudan University | Unknown | No outcome recorded |
| — | NCT02505880 | Jun 2015 → Jan 2018 | — | University Hospital, Montpellier | Completed | Met primary |
| — | NCT02490540 | Jun → Oct 2015 | — | University Hospital Hradec Kralove | Completed | No outcome recorded |
| — | NCT02710877 | Dec 2014 → Dec 2017 | — | University of Modena and Reggio Emilia | Terminated | No outcome recorded Stop: Business |
| — | NCT02488291 | Apr 2014 → Jun 2015 | — | Fudan University | Completed | No outcome recorded |
| — | NCT01856166 | Jun 2013 → Dec 2015 | pregnancy disorder | University Hospital, Montpellier | Completed | No outcome recorded |
| — | NCT02831101 | Feb 2012 → Nov 2015 | — | University Hospital, Geneva | Completed | No outcome recorded |
| — | NCT01917045 | Jan 2012 → Mar 2013 | — | Peking University First Hospital | Completed | No outcome recorded |
| — | NCT01505283 | Dec 2011 → Jul 2015 | — | Hopital Foch | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01086956 | Sep 2008 → Dec 2009 | prostate cancer | Yonsei University | Completed | No outcome recorded |
| — | NCT00434382 | Oct 2002 → Dec 2003 | — | Ludwig-Maximilians - University of Munich | Unknown | No outcome recorded |
| Comparator or background therapy193 trials | ||||||
| Phase 0 | NCT06570538 Comparator | Sep 2024 → May 2025 overdue | — | Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT03763084 Comparator | Feb 2019 → Feb 2020 | delirium, paracetamol poisoning | Xiangya Hospital of Central South University | Unknown | Missed primary |
| Phase 1 | NCT05742256 Comparator | Mar 2023 → Jul 2024 | — | Qianfoshan Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT04807335 Comparator | Mar → Jun 2021 | — | Cessatech A/S | Completed | No outcome recorded |
| Phase 2 | NCT07510217 Comparator | Aug 2024 → Dec 2025 | — | Tanta University | Completed | No outcome recorded |
| Show all 193 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 91
| Date | Issuer | Release |
|---|---|---|
| 2026-07-24 | Cessatech A/S | Regulatory Proveca intends to request a re-examination of CHMP opinion for CT001/KemSu cessatech.com ↗
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the Paediatric Use Marketing Authorisation (PUMA) application for CT001/KemSu (intranasal sufentanil/ketamine). |
| 2025-08-14 | Cessatech A/S | Regulatory Marketing Authorisation Application (MAA) for CT001 has been submitted to the European Medicines Agency (EMA) for acute pain management in children cessatech.com ↗
The Marketing Authorisation Application (MAA) for CT001 is submitted to the European Medicines Agency (EMA) for acute pain management in children |
| 2024-06-03 | Cessatech A/S | Results Cessatech announces superior simulated pain efficacy in children cessatech.com ↗
The simulated pain reduction in NRS in children using CT001 was -87%, compared to -52%, -32% and +10% for sufentanil, ketamine and placebo respectively. |
| 2023-08-25 | Cessatech A/S | Results New findings supporting CT001 cessatech.com ↗
The new 2023 meta-analysis by Fjendbo Galili et al. included more studies and found adjuvant subanesthetic ketamine does provide a significant reduction in pain scores at 60 minutes compared to opioids alone. |
| 2022-12-08 | Talphera, Inc | Results AcelRx Pharmaceuticals Announces European Peer-Reviewed Publication Supporting the Benefits of Sublingual Sufentanil Tablets For Post-Operative Pain Management in the Journal of Clinical Medicine talphera.com ↗
Patients reported lower pain scores, required fewer rescue doses and had a shorter hospital stay than patients receiving continuous femoral nerve block |
| 2022-10-31 | Talphera, Inc | Results AcelRx Pharmaceuticals Announces Presentation of a Large Cohort of Complex Plastic Surgery Procedures Performed with DSUVIA at Plastic Surgery The Meeting 2022 talphera.com ↗
The study of 324 complex plastic surgery procedures demonstrated many benefits of using DSUVIA for analgesia, including avoiding the need for general anesthesia |
| 2022-10-26 | Talphera, Inc | Results AcelRx Pharmaceuticals Announces Presentation of Investigator-Initiated Trial Results Comparing AcelRx's Sufentanil Sublingual Tablet (SST) Versus Intravenous Opioids for Postoperative Pain at the ANESTHESIOLOGY® Annual Meeting 2022 talphera.com ↗
The study found that patients who underwent major spine surgery had significantly lower reported postoperative pain scores when treated with sufentanil sublingual tablet (SST), 30 mcg (DSUVIA®) versus intravenous (IV) opioids. |
| 2022-05-19 | Talphera, Inc | Regulatory AcelRx Pharmaceuticals Provides Update on Reduced FDA REMS Requirements Related to DSUVIA® talphera.com ↗
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), ("AcelRx"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today reported that the U.S. Food and Drug Administration (FDA) has recently modified the DSUVIA Risk Evaluation and Mitigation Strategies (REMS) requirements with respect to healthcare setting audits. |
| 2022-05-10 | Talphera, Inc | Results AcelRx Pharmaceuticals Announces Publication of Results from an Investigator-Initiated Trial on Sufentanil Sublingual Tablet (SST) Compared to Standard Intravenous Opioids during Plastic Surgery Procedures Performed under General Anesthesia talphera.com ↗
Study found that SST lowered the opioid dose required by patients in the post-anesthesia care unit (PACU) by more than five-fold compared to standard intravenous opioid administration |
| 2022-04-25 | Talphera, Inc | Results Minimal Side Effects and Short Recovery Time Reported for DSUVIA®-Treated Patients: Plastic Surgery Podium Presentation at The Aesthetic Meeting 2022 talphera.com ↗
For patients undergoing general anesthesia, the control group required significantly more IV morphine milligram equivalents (MME) during recovery than SST-treated patients. |
| 2022-03-31 | Talphera, Inc | Results AcelRx Pharmaceuticals Announces Publication of Results from a Clinical Study Assessing Use of Sufentanil Sublingual Tablet for Painful Radiofrequency Microneedling Procedures talphera.com ↗
Study results show higher rates of successful procedure completion and higher patient and clinician satisfaction scores compared to topical local anesthesia alone |
| 2022-02-01 | Talphera, Inc | Results AcelRx Pharmaceuticals Announces Publication of Clinical Data on the Use of Sufentanil Sublingual Tablet during Awake Plastic Surgery Procedures talphera.com ↗ |
| 2021-12-15 | Talphera, Inc | Results AcelRx Pharmaceuticals Announces Publication of Clinical Data Showing Reduced Hospital Length of Stay and Reduced Opioid Utilization with Use of Sublingual Sufentanil in Total Joint Replacement Surgery talphera.com ↗ |
| 2021-08-30 | Talphera, Inc | Results Study Results Announced During Award-Winning Presentation on the Effect of Sufentanil Sublingual Tablet on Outpatient Plastic Surgery at the Annual Miami Cosmetic Surgery Event talphera.com ↗
Following the preoperative SST dose and local anesthetic infiltration, no other analgesics were required throughout the intraoperative and recovery period with recovery time averaging 15 ± 5 min. |
| 2021-06-17 | Talphera, Inc | Regulatory AcelRx Announces Agreement with FDA Addressing the Warning Letter Received for DSUVIA® Promotional Materials talphera.com ↗ |
| 2021-06-01 | Talphera, Inc | Results Rapid Discharge with Minimal PACU Opioids was Key Message During Presentation of DSUVIA® For Analgesia in Plastic Surgery Procedures at the California Society of Plastic Surgeons Annual Meeting talphera.com ↗
Patients undergoing short (< 1 hour) procedures required no opioids in the postanesthesia care unit (PACU) and had an average recovery time of 33 minutes with no adverse events reported. |
| 2021-05-13 | Talphera, Inc | Results Study of DSUVIA® Showing Significant Reduction in Postoperative Opioids and Better OBAS Scores Compared to Control Group to be Presented at the American Society of Regional Anesthesia (ASRA) Annual Meeting talphera.com ↗
However, patients in the SST group required 50% less opioids in the PACU (p=0.018), with significantly more of them opioid-free (36% vs 8%; p=0.037). |
| 2021-03-25 | Talphera, Inc | Results AcelRx Pharmaceuticals Announces Clinical Data Reporting High Ratings for Healthcare Professional and Patient Satisfaction Following Use of DSUVIA® for Acute Pain in Hospital Settings talphera.com ↗ |
| 2021-03-04 | Cessatech A/S | Results Favourable data from the Registry Safety Study cessatech.com ↗
No serious adverse events were reported for the use of sufentanil and s-ketamine in combination, confirming a favourable safety profile for this combination. |
| 2020-12-10 | Talphera, Inc | Results AcelRx Pharmaceuticals Announces Publication of Clinical Data on Decreased Postoperative Opioid Requirements and Enhanced Postanesthesia Recovery Following Perioperative Use of DSUVIA® talphera.com ↗ |
| 2020-09-14 | Cumberland Pharmaceuticals | Results Orthopedics This Week - The Effort to Reduce Opioid Use Gets A Boost From New Drugs cumberlandpharma.com ↗
Thankfully, that list is growing with recent publications supporting a pair of drugs that have been shown to reduce opioid use during and after surgery. |
| 2020-08-19 | Talphera, Inc | Results AcelRx Pharmaceuticals Announces Publication of Clinical Data on Reduced Opioid Use and Reduced Time in the Postanesthesia Care Unit (PACU) Following Preoperative Administration of DSUVIA® talphera.com ↗
Discharge from the PACU occurred 34% faster than controls (36.3 min vs. 54.9 min; p < 0.001). |
| 2019-11-13 | Talphera, Inc | Results AcelRx Pharmaceuticals Announces Publication Analyzing Pooled Dosing and Efficacy Data on Sufentanil Sublingual 30 mcg Tablets talphera.com ↗
Summed pain intensity difference to baseline over 12 hours (SPID12) was higher (superior) in the SST 30-mcg group compared with placebo across all demographic subgroups. |
| 2019-04-11 | Talphera, Inc | Results AcelRx Pharmaceutical's pooled safety results for sufentanil sublingual tablets (DSUVIA) selected for presentation at 44th Annual Regional Anesthesiology & Acute Pain Medicine Meeting talphera.com ↗
These pooled results from our numerous clinical trials support the safe use of sufentanil sublingual tablets across a broad age range of patients in the emergency department and following a wide variety of surgeries. |
| 2019-01-07 | Talphera, Inc | Results AcelRx Pharmaceuticals announces publication analyzing pooled data on sufentanil sublingual tablets for short-term treatment of moderate-to-severe acute pain talphera.com ↗
Across all of the AcelRx studies, adverse events (AEs) were experienced by 60.5% of patients in the SST group, and 61.4% in the placebo group. |
| 2018-11-14 | Talphera, Inc | Results AcelRx Pharmaceuticals to Present at the 17th Annual ASRA Pain Medicine Meeting talphera.com ↗
Over the first five hours, patient dosing in each treatment arm suggests that a single 15 mcg or 30 mcg tablet has the equivalent analgesic effect to approximately 2.5 mg or 5 mg of IV morphine, respectively. |
| 2018-11-02 | Talphera, Inc | Regulatory AcelRx Pharmaceuticals Reports Third Quarter 2018 Financial Results and Provides Corporate Update talphera.com ↗
On November 2, 2018 , the FDA approved the New Drug Application (NDA) for DSUVIA for use in adults in a certified medically supervised healthcare setting for the management of acute pain. |
| 2018-11-02 | Talphera, Inc | Regulatory AcelRx announces FDA approval of DSUVIA™ talphera.com ↗
AcelRx Pharmaceuticals, Inc. (AcelRx) (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in a medically supervised setting, announced today the approval of DSUVIA™ by the U.S. Food and Drug Administration ( FDA ). |
| 2018-10-19 | Talphera, Inc | Regulatory AcelRx Provides Updated Comments Following Positive FDA Advisory Committee Meeting talphera.com ↗
The Committee voted 10-3 in favor of recommending the approval of DSUVIA for the management of moderate-to-severe acute pain in medically supervised settings for adult patients. |
| 2018-10-15 | Talphera, Inc | Results DSUVIA Efficacy and Safety Data to be Presented at the American Society of Anesthesiologists (ASA) Annual Conference talphera.com ↗
Statistically significant SPID12 differences were observed in favor of DSUVIA compared to placebo. |
| 2018-10-12 | Talphera, Inc | Regulatory FDA Advisory Committee Recommends Approval Of DSUVIA For The Treatment Of Moderate-To-Severe Acute Pain talphera.com ↗
the Anesthetic and Analgesic Drug Products Advisory Committee of the U.S. Food and Drug Administration ( FDA ) voted 10-3 in favor of recommending the approval of DSUVIA™ |
| 2018-06-27 | Talphera, Inc | Regulatory AcelRx receives European Commission approval for DZUVEO™ talphera.com ↗ |
| 2018-05-24 | Talphera, Inc | Regulatory AcelRx announces FDA acceptance of NDA for DSUVIA talphera.com ↗
Therefore, the FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal date of November 3, 2018 . |
| 2018-05-09 | Talphera, Inc | Regulatory AcelRx resubmits New Drug Application for DSUVIA™ talphera.com ↗
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, today announced the resubmission of the New Drug Application (NDA) for DSUVIA with the U.S. Food and Drug Administration ( FDA ). |
| 2018-04-27 | Talphera, Inc | Regulatory AcelRx receives positive CHMP opinion for DZUVEO™ for management of acute moderate to severe pain in medically monitored settings talphera.com ↗ |
| 2018-04-18 | Talphera, Inc | Results AcelRx Pharmaceuticals Announces Publication Concluding that Sublingual Sufentanil Tablets Provide the Opportunity to Non-Invasively and Rapidly Treat Moderate-To-Severe Acute Pain in a Monitored Setting talphera.com ↗
The study concluded that sublingual sufentanil tablets provide the opportunity to non-invasively and rapidly treat moderate-to-severe pain in a monitored setting. |
| 2017-11-16 | Talphera, Inc | Results AcelRx Pharmaceuticals Reports Publication of Manuscript Analyzing Sufentanil Sublingual Tablets in Patients with Postoperative Pain talphera.com ↗
Conclusions of the study highlighted that sufentanil sublingual tablet 30 mcg was effective and well-tolerated for the management of moderate-to-severe acute pain following a variety of surgical procedures, including knee replacement, open-abdominal surgery and bunionectomy. |
| 2017-11-09 | Talphera, Inc | Results AcelRx Pharmaceuticals Reports Publication of Manuscript Evaluating Sufentanil Sublingual Tablets for Moderate-to-Severe Acute Pain in the Emergency Department talphera.com ↗
Conclusions of this study indicated that sufentanil sublingual tablet 30 mcg demonstrated clinically meaningful management of moderate-to-severe acute pain in an ED setting. |
| 2017-10-12 | Talphera, Inc | Regulatory AcelRx Pharmaceuticals Receives Complete Response Letter from the FDA for DSUVIA™ NDA talphera.com ↗
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) (AcelRx), a specialty pharmaceutical company, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration ( FDA ) regarding its New Drug Application (NDA) for DSUVIA ™ (sufentanil sublingual tablet), 30 mcg. |
| 2017-08-01 | Talphera, Inc | Results AcelRx Pharmaceuticals Reports Successful Outcome of ZALVISO Phase 3 IAP312 Study on Device Functionality talphera.com ↗
Throughout the study in 320 enrolled patients, 2.2% of patients experienced a ZALVISO device error, which was statistically less than the 5% limit specified in the study objectives. |
| 2017-08-01 | Talphera, Inc | Results AcelRx Pharmaceuticals Reports Second Quarter 2017 Financial Results and Provides Corporate Update talphera.com ↗
Today AcelRx reported top-line results from IAP312, a Phase 3 study that treated 320 hospitalized, post-operative patients who used ZALVISO to self-administer 15 mcg sublingual sufentanil tablets as often as once every 2 |
| 2017-04-06 | Talphera, Inc | Results AcelRx Pharmaceuticals Presenting Comprehensive DSUVIA Clinical Trial Results at ASRA's Annual Regional Anesthesiology and Acute Pain Medicine Meeting talphera.com ↗
In the emergency department study, DSUVIA resulted in a 3-point reduction in pain intensity within 60 minutes of administration, with clinically meaningful relief within 15-30 minutes. |
| 2017-03-28 | Talphera, Inc | Regulatory European Medicines Agency Begins Evaluation of Marketing Application for Sublingual Sufentanil 30 mcg Tablet (ARX-04) for Moderate-to-Severe Acute Pain talphera.com ↗ |
| 2017-03-02 | Talphera, Inc | Regulatory AcelRx Pharmaceuticals Reports Fourth Quarter and Year End 2016 Financial Results talphera.com ↗
Recently, this application was accepted for filing, and a Prescription Drug User Fee Act (PDUFA) goal date of October 12, 2017 was assigned. |
| 2017-02-27 | Talphera, Inc | Regulatory AcelRx Pharmaceuticals' New Drug Application for DSUVIA Accepted for Filing with PDUFA Date of October 12, 2017 talphera.com ↗
The acceptance of the NDA indicates that the FDA has deemed the application sufficiently complete to allow a substantive review. |
| 2017-02-13 | Talphera, Inc | Results AcelRx Pharmaceuticals Presentation at JAB Burn Symposium Highlights Potential of DSUVIA™ for Use in Burn Victims with Moderate-to-Severe Acute Pain talphera.com ↗
After a single DSUVIA dose, each patient reported a 2-point decrease in pain intensity within 15 minutes. |
| 2016-12-13 | Talphera, Inc | Regulatory AcelRx Pharmaceuticals Submits New Drug Application for ARX-04 for the Treatment of Moderate-To-Severe Acute Pain talphera.com ↗
announced that it has submitted a New Drug Application (NDA) under section 505(b)(2) with the U.S. Food and Drug Administration ( FDA ) for ARX-04 |
| 2016-11-17 | Talphera, Inc | Results AcelRx Pharmaceuticals Unveiling Results of ARX-04 SAP303 Study in Post-Operative Setting at the Annual ASRA Pain Medicine Meeting talphera.com ↗
The presentation is part of the Emerging Technology Moderated Poster session and will mark the first presentation of complete results from the Phase 3 SAP303 study of ARX-04 (sufentanil sublingual tablet, 30 mcg). |
| 2016-10-31 | Talphera, Inc | Results AcelRx Pharmaceuticals to Present ARX-04 Analysis for Treatment of Moderate-to-Severe Acute Pain in Obese Patients at The Obesity Society Annual Meeting talphera.com ↗
Overall, while sample sizes were limited, the conclusion of this analysis was that safety and efficacy results were consistent across the entire study population, regardless of BMI. |
| 2016-09-28 | Talphera, Inc | Results AcelRx Pharmaceuticals Presenting ARX-04 Clinical Trial Findings and Cost Analysis at European Congress on Emergency Medicine talphera.com ↗
Results from this trial showed substantial reductions in pain intensity (mean 2.9 out of 10 on a validated pain scale) within the first hour among the 76 patients treated with ARX-04. |
| 2016-09-22 | Talphera, Inc | Results Findings from AcelRx Pharmaceuticals' Phase 3 SAP301 Study of ARX-04 in Abdominoplasty Patients to be Presented at Plastic Surgery Meeting talphera.com ↗
This cohort demonstrated statistical significance vs placebo (31.8 vs 17.6; p=0.001) for the primary efficacy endpoint of the summed pain intensity difference to baseline over the 12-hour study period (SPID-12). |
| 2016-09-15 | Talphera, Inc | Results AcelRx Reports Positive Results for ARX-04 (sufentanil sublingual tablet, 30 mcg), Including in Elderly Patients and Patients with Organ Impairment, in Third Phase 3 Registration Trial, SAP303 talphera.com ↗
Regardless of age and organ function, approximately 2 in 3 patients had no adverse events during the study (63% of all patients, 63% of those aged ≥65 years, 62% of those with hepatic impairment, 70% of those with renal impairment). |
| 2016-08-29 | Talphera, Inc | Results AcelRx Pharmaceuticals Presents Results from Phase 3 Study of ARX‑04 in the Emergency Department at the International Society for Burn Injuries talphera.com ↗
As previously reported, adult patients treated with ARX-04 in this study experienced a mean pain intensity difference of 2.9 from a baseline of 8.1 on a validated 0 – 10 numeric rating scale at 60 minutes, meeting the study's primary objective. |
| 2016-08-15 | Talphera, Inc | Results AcelRx Pharmaceuticals' ARX-04 Phase 3 Trial Met its Primary Endpoint, Reduced Pain Intensity in ER Patients with Moderate-to-Severe Acute Pain talphera.com ↗
Overall, the 76 adults treated with ARX-04 in this study experienced a mean pain intensity difference to baseline (PID) of 2.9 from a baseline of 8.1, or 35%, on a 0 – 10 numeric rating scale at 60 minutes. |
| 2016-08-01 | Talphera, Inc | Results AcelRx Pharmaceuticals to Present Initial Results of Phase 3 Study of ARX‑04 at World Congress of Mountain & Wilderness Medicine talphera.com ↗ |
| 2016-05-26 | Talphera, Inc | Results AcelRx Pharmaceuticals Presents Results from Phase 3 Study of ARX‑04 following Ambulatory Abdominal Surgeries at Euroanaesthesia talphera.com ↗
The study met its primary endpoint with statistically significant pain intensity differences to baseline over the 12-hour study period (SPID12) in favor of ARX-04 (p<0.001). |
| 2016-02-25 | Talphera, Inc | Results AcelRx Pharmaceuticals' Moderate-to-Severe Acute Pain Candidate ARX-04 Shows Improved Pain Scores in ER Patients in Interim Phase 3 Analysis talphera.com ↗
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, today reported encouraging interim efficacy and safety results of the ongoing single-arm, open-label Phase 3 study (SAP302) of ARX-04 for the treatment of adult patients who present in the emergency room with moderate-to-severe acute pain associated with trauma or injury. |
| 2015-12-23 | Talphera, Inc | Regulatory AcelRx Pharmaceuticals Receives Notice of Eligibility for Centralized Review of ARX-04 from European Medicines Agency talphera.com ↗ |
| 2015-11-04 | Talphera, Inc | Results AcelRx Pharmaceuticals Presents Data from Phase 3 Clinical Trials Evaluating the Safety and Efficacy of Zalviso in Obese Surgical Patients talphera.com ↗
Specifically, patients who self-administered Zalviso experienced statistically significantly improved pain relief when compared to self-administered IV morphine as measured by pain intensity difference to baseline (PID). |
| 2015-10-23 | Talphera, Inc | Results AcelRx Pharmaceuticals Announces Presentation Of Phase 3 Data From ARX-04 Sufentanil Sublingual 30 mcg Program At The American Society Of Anesthesiology Meeting talphera.com ↗ |
| 2015-09-22 | Talphera, Inc | Regulatory AcelRx Pharmaceuticals Reports that the European Commission has Granted Marketing Authorization for Zalviso™ for Treatment of Acute Moderate-to-Severe Post-Operative Pain in Adult Patients talphera.com ↗
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) (AcelRx) announced today that the European Commission (EC) has approved Zalviso™ (15 micrograms sufentanil sublingual tablets) for the management of acute moderate-to-severe post-operative pain in adult patients. |
| 2015-09-09 | Talphera, Inc | Results AcelRx Pharmaceuticals' ARX-04 Meets all Endpoints in Pivotal Phase 3 Study for Moderate-to-Severe Acute Pain talphera.com ↗ |
| 2015-07-24 | Talphera, Inc | Regulatory AcelRx Announces Positive CHMP Opinion for Zalviso in the Management of Acute Moderate-to-Severe Post-Operative Pain in Adult Patients talphera.com ↗
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for Zalviso™ (sufentanil sublingual tablets). |
| 2015-07-02 | Talphera, Inc | Results Zalviso™ Phase 3 Orthopedic Results Published In Anesthesiology Demonstrate Significant Reductions In Post-Operative Pain talphera.com ↗
The study met its primary endpoint, demonstrating that Zalviso was significantly better at managing pain over 48 hours as measured by Summed Pain Intensity Difference to Baseline ( SPID -48), than placebo (p<0.001). |
| 2015-05-04 | Talphera, Inc | Regulatory AcelRx Pharmaceuticals Provides Zalviso Regulatory Update and Reports First Quarter 2015 Financial Results talphera.com ↗
This past Friday the Division notified the Company that the request for a meeting was denied and restated the Division's view that a clinical study is required. |
| 2015-03-09 | Talphera, Inc | Regulatory AcelRx Provides Regulatory Update on Zalviso talphera.com ↗ |
| 2014-12-02 | Talphera, Inc | Regulatory AcelRx Pharmaceuticals Receives CE Mark Approval for Zalviso talphera.com ↗
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain today announced that it has received CE Mark approval (Conformite Europeenne) for the Zalviso device. |
| 2014-10-22 | Talphera, Inc | Results AcelRx Announces Publication of Zalviso Phase 3 Abdominal Trial Results talphera.com ↗
The study met its primary endpoint, demonstrating that Zalviso was significantly better at managing pain over 48 hours as measured by Summed Pain Intensity Difference to Baseline ( SPID -48), than placebo (p=0.001). |
| 2014-10-06 | Talphera, Inc | Results Sufentanil sublingual tablet system study results to be presented at the International Association for the Study of Pain Meeting talphera.com ↗
The integrated analysis additionally yielded statistically significant onset of analgesia differences in favor of SSTS over IV PCA as measured by pain intensity reduction from baseline, a common outcome variable. |
| 2014-09-04 | Talphera, Inc | Results AcelRx Announces Publication of Sufentanil Sublingual Tablet System vs. Intravenous Patient-Controlled Analgesia with Morphine for Postoperative Pain Study Results talphera.com ↗
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced the publication of the results of a study to evaluate patient satisfaction with a novel sublingual sufentanil patient-controlled analgesia (PCA) system compared to the standard intravenous PCA for the management of acute postoperative pain. |
| 2014-07-25 | Talphera, Inc | Regulatory AcelRx Pharmaceuticals Receives Complete Response Letter from FDA for New Drug Application for Zalviso™ talphera.com ↗
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that the U.S. Food and Drug Administration ( FDA ) has issued a Complete Response Letter (CRL) for the Company's new drug application (NDA) for Zalviso™ (sufentanil sublingual tablet system). |
| 2014-07-07 | Talphera, Inc | Regulatory AcelRx and Grunenthal Announce Submission of European Marketing Authorization Application for ZALVISO™ talphera.com ↗
Under the terms of the license agreement, AcelRx will receive a cash payment of $5 million for the MAA submission. |
| 2013-12-13 | Talphera, Inc | Results AcelRx Pharmaceuticals Presents ARX-04 Dose-Finding Phase 2 Study Data at Anesthesia Medical Conference talphera.com ↗
Patients treated with the 30 mcg dose of sufentanil showed a rapid onset of action with a statistically significant beneficial difference in pain relief (p<0.001) and pain intensity (p<0.01) seen at 30 minutes after dosing compared to placebo. |
| 2013-12-02 | Talphera, Inc | Regulatory Zalviso™ New Drug Application Accepted for Filing by FDA talphera.com ↗ |
| 2013-09-30 | Talphera, Inc | Regulatory AcelRx Pharmaceuticals Submits New Drug Application to the FDA for Zalviso™ talphera.com ↗
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for Zalviso™ (sufentanil sublingual microtablet system). |
| 2013-05-21 | Talphera, Inc | Results Top-line Data Demonstrate Primary Endpoint Achieved in Final Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Management of Post-Operative Pain talphera.com ↗
Results demonstrated that patients receiving sufentanil NanoTabs realized a significantly greater SPID -48 during the study period than placebo-treated patients (+76.1 vs -11.5, p<0.001). |
| 2013-05-02 | Talphera, Inc | Results AcelRx Pharmaceuticals Presents Positive Clinical Data for the Sufentanil NanoTab PCA System at ASRA Medical Meeting talphera.com ↗
In addition, there were fewer patients throughout the study that experienced oxygen desaturation events below 95% in the Sufentanil NanoTab PCA System group than in the IV PCA morphine group (p=0.028). |
| 2013-04-24 | Talphera, Inc | Results Top-line Data Show AcelRx Pharmaceuticals' ARX-04 Achieves Primary Endpoint in Dose-Finding Phase 2 Clinical Trial talphera.com ↗
Patients in the 30 mcg sufentanil NanoTab treatment group experienced significantly greater reduction in pain as measured by SPID-12 vs. placebo |
| 2013-03-04 | Talphera, Inc | Results AcelRx Top-line Data Show Primary Endpoint Achieved in Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Post-Operative Pain in Major Open Abdominal Surgery Patients talphera.com ↗
Results demonstrated that patients receiving sufentanil NanoTabs realized a significantly greater SPID -48 during the study period than placebo-treated patients (p=0.001). |
| 2012-12-14 | Talphera, Inc | Results AcelRx to Present Top-Line Data from Phase 3 Study of Sufentanil NanoTab® PCA System vs. IV PCA Morphine at the 66th Annual PostGraduate Assembly in Anesthesiology held in New York City talphera.com ↗
Top-line results of the Phase 3 clinical trial demonstrate that the Sufentanil NanoTab PCA System was non-inferior (p<0.001) to intravenous (IV) patient-controlled analgesia (PCA) with morphine |
| 2012-11-15 | Talphera, Inc | Results AcelRx Announces Primary Endpoint Met in Phase 3 Non-Inferiority Study of Sublingual Sufentanil NanoTab® PCA System vs. IV PCA Morphine for Post-Operative Pain talphera.com ↗ |
| 2012-11-14 | Talphera, Inc | Results AcelRx Announces Achievement of the Primary End-Point in Phase 3 Comparative Study Involving the Sufentanil NanoTab PCA System and Plans to Hold a Conference Call and Webcast Tomorrow to Discuss Top-Line Results talphera.com ↗
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, announced today it had met the primary endpoint in the Phase 3 non-inferiority study of the sublingual Sufentanil NanoTab PCA System vs. IV PCA with morphine. |
| 2012-10-03 | Talphera, Inc | Regulatory AcelRx Receives Notice of Eligibility for Centralized Review from European Medicines Agency for the Sufentanil NanoTab® PCA System talphera.com ↗
today announced a decision by the European Medicines Agency , or EMA, to permit registration of the Sufentanil NanoTab PCA System (ARX-01) via the centralized procedure under Article 3(2) (b) of Regulation EC 726/2004. |
| 2011-05-18 | Talphera, Inc | Results ARX-01 and ARX-03 Clinical Results Presented at the 30th Annual Scientific Meeting of the American Pain Society talphera.com ↗
The results from the 212 patients included in these three studies indicate that ARX-01 was effective in treating both major orthopedic and major abdominal post-operative pain with minimal adverse effects. |
| 2010-05-25 | Talphera, Inc | Results AcelRx Announces Positive Phase 2 Results from a Study of ARX-02 Sufentanil NanoTab™ Breakthrough Pain Management System in Treating Cancer Breakthrough Pain talphera.com ↗
AcelRx Pharmaceuticals, Inc. today announced positive results from a Phase 2 clinical study evaluating the safety and efficacy of the ARX-02 Sufentanil NanoTab Breakthrough Pain Management System in the treatment of cancer breakthrough pain in opioid-tolerant patients. |
| 2010-04-20 | Talphera, Inc | Results AcelRx Sufentanil NanoTab PCA System (ARX-01) Phase 2 Results Featured in Poster Presentations at the 35th Annual Meeting of the American Society of Regional Anesthesia and Pain to be held in Toronto on April 22-25th talphera.com ↗
All three studies demonstrated that ARX-01 provided safe and effective post-operative analgesia, with patients receiving ARX-01 reporting statistically significant reductions in pain intensity over the 12-hour study period compared to placebo. |
| 2009-10-22 | Talphera, Inc | Results AcelRx Announces Positive Results from a Phase 2 Study of ARX-03, a Sufentanil/Triazolam NanoTab for Procedural Sedation, Anxiolysis & Analgesia talphera.com ↗
AcelRx Pharmaceuticals, Inc. today announced positive results from a Phase 2 clinical trial of ARX-03, a proprietary sublingual dosage form combining an opioid, sufentanil, with a benzodiazepine, triazolam. |
| 2009-07-22 | Talphera, Inc | Results AcelRx Announces Perfect Performance of Handheld Component of ARX-01 Sufentanil NanoTab PCA System in a Phase 2 Study talphera.com ↗
There were no System failures or dosing errors of any kind throughout the study, which included over 375 dispensed NanoTabs. |
| 2009-06-29 | Talphera, Inc | Results AcelRx Announces Positive Phase 2 Results from a Study of ARX-01 Sufentanil NanoTabs in Treating Post-Operative Pain talphera.com ↗
AcelRx Pharmaceuticals, Inc. today announced positive results from the second Phase 2 clinical study evaluating the safety and efficacy of its ARX-01 Sufentanil NanoTabs™ for the management of acute post-operative pain in patients requiring opioid analgesia during hospitalization. |
| 2009-01-12 | Talphera, Inc | Results AcelRx Pharmaceuticals Reports Positive Results from a Clinical Trial of Sublingual Sufentanil/Triazolam NanoTab™ talphera.com ↗
AcelRx Pharmaceuticals, Inc., an emerging specialty pharmaceutical company focused on the treatment of intermittent and acute medical conditions with an initial emphasis on pain management, today announced positive results from a Phase 1 clinical study evaluating the safety, tolerability and efficacy of the company’s proprietary sublingual sufentanil (opioid) and triazolam (benzodiazepine) NanoTab™ combination product candidate (ARX‐03). |
| 2008-12-09 | Talphera, Inc | Results AcelRx Pharmaceuticals, Inc. today announced positive results from a Phase 2 clinical study talphera.com ↗
Results demonstrated that compared to placebo, patients receiving 15 mcg of ARX‐01 experienced a statistically significant reduction in pain intensity over the study period, based on the worst observation carried forward imputation method (WOCF), p=0.015. |
All press releases naming this drug 152 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 152 releases opens the full record — a long page | ||
Evidence & citations 27 cited values
Every value below carries the sentence it was read from. 308 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sufentanil | “After surgery, patient-controlled intravenous analgesia will be established with dexmedetomidine (DEX 1.5 ug/ml), esketamine (ESK 0.5 mg/ml), and sufentanil (1.25 ug/ml),...” NCT07523321 ↗291“Postoperative patient-controlled analgesia will be established with a 100 mL mixture (containing 1.0 μg/mL sufentanil, 1.25 μg/mL dexmedetomidine, and 0.25 mg/mL esketamine in...” NCT07576517 ↗ “The parturients were randomly assigned to groups receiving either spinal sufentanil (5 µg), epidural sufentanil (20 µg), spinal fentanyl (20 µg) or epidural fentanyl (100 µg),...” PMID 31286476 ↗ Jul 2019 “Epidural block is widely used as an analgesic method during labor. During epidural anaesthesia, lipophilic opioids such as sufentanil, are often combined with local anesthetics...” NCT03395600 ↗ “The study solutions were either 0.568 mg x ml(-1) levobupivacaine (low concentration group) or 1.136 mg x ml(-1) levobupivacaine (high concentration group), with sufentanil...” PMID 20565392 ↗ Jun 2010 “The aim of this study was to compare the recovery of 2 Bispectral index (BIS)-guided anesthesia protocols combining sevoflurane-sufentanil (SS) or propofol-remifentanil (PR)...” PMID 23774117 ↗ Jan 2014 “Open-label, Prospective Study to Assess the Safety, Tolerability, Analgesic Effect and Feasibility of Intranasal Sufentanil/Ketamine in Pediatric Patients With Moderate or...” NCT06364072 ↗ “Sufentanil, unlike morphine and hydromorphone, avoids the issue of active metabolites that can lead to prolonged, untoward effects, which can complicate postoperative care and...” NCT04263909 ↗ “This typically involves the intravenous (IV) administration of strong opioids such as Fentanyl or Sufentanil to manage the intense pain during the craniotomy (bone flap...” NCT07510217 ↗ “Remimazolam 6mg/kg/h was pumped intravenously for 2.5 min, Sufentanil 0.5 μg/kg and rocuronium 0.6mg/kg were injected intravenously, and endotracheal intubation was performed 3...” NCT06775366 ↗ “Postoperative analgesia was provided by patient-controlled intravenous sufentanil, supplemented by randomly assigned dexmedetomidine (1.25 μg/mL) or placebo, for up to three days.” PMID 34517840 ↗ Sep 2021 |
| Known as | ARX-F01 | “A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing...” NCT00718081 ↗1“the ARX-F01 pain medication (Sufentanil NanoTab 15 mcg) for the treatment of post-operative pain” NCT00859313 ↗ |
| Known as | Brand name:Sufenta | “Brand name:Sufenta” NCT01572116 ↗ |
| Known as | Dsuvia | “Randomized, interventional trial of Emergency Department (ED) administration of DSUVIA (sufentanil) versus standard care pain management comparing pain treatment outcomes in...” NCT05288348 ↗1“sublingual sufentanil (Dsuvia) will improve postoperative pain management” NCT04716413 ↗ |
| Known as | Dzuveo | “including sublingual sufentanil (Dzuveo®, 30 µg), which combines opioid-like effects with a faster onset of action due to its lipophilicity.” NCT07624006 ↗ |
| Known as | IDS-NS-001 | ChEMBL registry synonym — accepted as the source's own label CHEMBL658 ↗ |
| Known as | R 33800 | ChEMBL registry synonym — accepted as the source's own label CHEMBL658 ↗ |
| Known as | R30730 | “Sufentanil (R30730, brand name Sufenta)” NCT01917045 ↗ |
| Known as | Sufenta | “Sufentanil (R30730, brand name Sufenta)” NCT01917045 ↗ |
| Known as | Sufenta preservative free | ChEMBL registry synonym — accepted as the source's own label CHEMBL658 ↗ |
| Known as | Sufental | ChEMBL registry synonym — accepted as the source's own label CHEMBL658 ↗ |
| Known as | sufentanil (DSUVIA) | “sufentanil (DSUVIA)” NCT05307341 ↗ |
| Known as | Sufentanil = Sufenta | “Sufentanil = Sufenta” NCT01367418 ↗ |
| Known as | Sufentanil Citrate | “Sufentanil Citrate injection, specification: 50 ug/ml, 1 ml; Avoid light seal; Yichang humanwell pharmaceutical co., LTD.” NCT06530563 ↗ |
| Known as | Sufentanil citrate cii | ChEMBL registry synonym — accepted as the source's own label CHEMBL658 ↗ |
| Known as | Sufentanil Injection | “Drug: Sufentanil Injection” NCT04067648 ↗1“sufentanil injection” NCT06530563 ↗ |
| Known as | Sufentanil NanoTab | “the ARX-F01 pain medication (Sufentanil NanoTab 15 mcg) for the treatment of post-operative pain” NCT00859313 ↗1“Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours” NCT01710345 ↗ |
| Known as | Sufentanil, Sufenta, (R-30730) | “Sufentanil, Sufenta, (R-30730)” NCT01406678 ↗ |
| Known as | Sufentanil: Fentatienil, Angelini, Rome, Italy. | “Sufentanil: Fentatienil®, Angelini, Rome, Italy.” NCT01860521 ↗ |
| Known as | Sufentanilo | ChEMBL registry synonym — accepted as the source's own label CHEMBL658 ↗ |
| Known as | Sufentanyl | “Midazolam 0.03 mg/kg injection vein，Sufentanyl 0.5\~1 μg/kg, target controlled infusion of etomidate or propofol,after the consciousness of patients is lost, rocuronium...” NCT02644980 ↗12“A combined spinal epidural anesthesia with spinal administration of 50 mg hyperbaric prilocaine 2% (Tachipri, Nordic Pharma) + 2,5mcg sufentanyl (5 mcg/ml) (Janssens-cilag)” NCT03219086 ↗ “Midazolam 0.05 mg/kg、Propofol 1.0 mg/kg、Sufentanyl 3μg/kg、Victracurium 0.1 mg/kg sequential intravenous injection” NCT02123355 ↗ “The patient will receive the intravenous opioid analgesic sufentanyl 0.2 mcg/kg over a period of 30 seconds.” NCT07456111 ↗ “spinal anesthesia with 10 mg hyperbaric Bupivacaïne 0,5% + 2,5 µ Sufentanyl + 100 µ of intrathecal Morphine” NCT02711072 ↗ “propofol 2mg kg-1, sufentanyl 0.3-0.5 μ g kg-1, rocuronium” NCT06493396 ↗ “using sufentanyl 5mg intravenously during the surgery” NCT05815056 ↗ |
| Known as | Zalviso | “Patients used the Zalviso™ (sufentanil sublingual tablet system) 15 mcg to self-administer a tablet of study drug as needed for pain.” NCT02662764 ↗ |
| Known as | Zalviso (sufentanil sublingual tablet system) 15 mcg | “Zalviso™ (sufentanil sublingual tablet system) 15 mcg” NCT02662764 ↗ |
| Action | Activate | “Mu opioid receptor agonist” CHEMBL658 ↗1“a pure μ receptor agonist” NCT03685188 ↗ |
| Modality | Other / unclassified | “Sufentanil (medium/long acting opioid)” NCT02053818 ↗ |
| Route | Other | “The addition of clonidine to epidural levobupivacaine and sufentanil for patient-controlled epidural analgesia in labour improved analgesia, reduced the supplementation rate...” PMID 20299988 ↗ May 2010 |
| Target | OPRM1 | “Mu opioid receptor agonist” CHEMBL658 ↗ |