Drugs / buprenorphine/naloxone
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | SUBOXONE Film | opiate dependence | 2019-03-08 | “The SUBOXONE Film MAA was submitted to the EMA on March 8, 2019.” indivior.com ↗ |
| Filed | US (FDA) | Zubsolv | opiate dependence | 2013-01-31 | “The most important event was the submission of the New Drug Application for Zubsolv™ (buprenorphine/naloxone) in the USA.” orexo.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT05368675 | Dec 2013 → Aug 2017 | HIV infectious disease, opiate dependence | University of Pennsylvania | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2019-06-18 | Indivior Inc. | Regulatory Indivior | Indivior Announces Validation of Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for SUBOXONE (buprenorphine and naloxone) Sublingual Film indivior.com ↗
Indivior PLC (LON: INDV) (the ‘Company’), a global specialty pharmaceutical company with a 20-year legacy of leadership in developing medicines to treat opioid use disorder (OUD), today announced that the European Medicines Agency (EMA) has completed formal validation of Indivior’s Marketing Authorization Application (MAA) for SUBOXONE Film. |
| 2018-06-15 | Indivior Inc. | Regulatory Indivior | Indivior Responds to Generic SUBOXONE® Approvals and Dr. Reddy’s Launch “At-Risk” indivior.com ↗
the US FDA approved generic versions of SUBOXONE® Film from both Dr. Reddy’s and Mylan |
| 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. |
All press releases naming this drug 10 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | buprenorphine/naloxone | “The program includes medication for opioid use disorder (methadone, buprenorphine/naloxone), standardized counseling sessions (BDRC) and HIV testing and care (for people living...” NCT05368675 ↗ |
| Known as | Suboxone | “This is the first project to establish and evaluate the implementation a buprenorphine/naloxone (Suboxone) treatment program in Vietnam.” NCT05368675 ↗ |