Drugs / RBP-6000
RBP-6000
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | opiate dependence | 2017-05-30 | “submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) to seek marketing approval for RBP-6000” indivior.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02559973 | Sep 2015 → Feb 2016 | substance-related disorder | Indivior Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03002961 | Jul 2012 → Feb 2013 | opiate dependence | Indivior Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01738503 | Oct 2012 → May 2014 | opiate dependence | Indivior Inc. | Completed | No outcome recorded |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT03809143 | May 2019 → Nov 2020 | opiate dependence | The University of New South Wales | Unknown | No outcome recorded |
| Phase 3 | NCT02896296 | Aug 2016 → Aug 2017 | substance-related disorder | Indivior Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02510014 | Jul 2015 → Jan 2017 | substance-related disorder | Indivior Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02357901 | Jan 2015 → Apr 2016 | opiate dependence | Indivior Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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 ↗ |
| 2017-10-31 | 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). |
| 2017-10-03 | Indivior Inc. | Regulatory Indivior | FDA Posts Advisory Committee Meeting Notice for RBP-6000 NDA indivior.com ↗ |
| 2017-07-31 | Indivior Inc. | Regulatory Indivior | Indivior RBP-6000 NDA Acceptance with Priority Review Designation indivior.com ↗ |
| 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 ↗ |
| 2017-05-30 | 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. |
| 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. |
All press releases naming this drug 20 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RBP-6000 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03002961 ↗ |
| Known as | BPN | “RBP-6000 (BPN in the ATRIGEL® Delivery System) contains buprenorphine (200mg/mL) in the ATRIGEL® Delivery System, which provides sustained plasma level of BPN over a minimum of 28 days.” NCT03809143 ↗ |
| Known as | BUP-XR | “RBP-6000, referred to as BUP-XR (extended-release buprenorphine), is a subcutaneously injected, monthly buprenorphine treatment for opioid use disorder.” PMID 30792007 ↗ Feb 2019 |
| Known as | Depot Buprenorphine | “A Multicenter, Open-Label, Single Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Depot Buprenorphine (RBP-6000) in Opioid-Dependent Subjects” NCT03002961 ↗ |
| Route | Subcutaneous | “subcutaneous (SC) injection using the ATRIGEL® Delivery System” NCT01738503 ↗ |