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 | — | “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 2 | NCT04234191 | Aug 2021 → Jan 2025 | opiate dependence | University of British Columbia | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 2016-08-17 | 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. |
| 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 12 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Buprenorphine/naloxone | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04234191 ↗ |
| Known as | Suboxone | “BACKGROUND: Buprenorphine/naloxone (Suboxone) is a current first-line treatment for opioid use disorder (OUD).” PMID 33579359 ↗ Feb 2021 |
| Route | Other | “It is administered via sublingual tablet form.” NCT04234191 ↗ |