Drugs / Buprenorphine/naloxone
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | ZUBSOLV | opiate dependence | 2014-10-13 | “The most important event was the submission of the New Drug Application for Zubsolv™ (buprenorphine/naloxone) in the USA.” orexo.com ↗ “submitted an application to the U.S. Food and Drug Administration (FDA) for an expanded label of ZUBSOLV” orexo.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01848054 | Jun 2013 → Jan 2014 | opiate dependence | Orexo AB | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2021-01-29 | Orexo AB | Regulatory Orexo expects FDA filing of OX124 mid 2022 orexo.com ↗
OX124 is expected to follow the FDA’s standard submission and review timelines, as the FDA did not grant Fast Track Designation to the product. |
| 2015-08-11 | Orexo AB | Regulatory U.S. FDA Approves ZUBSOLV® for Induction of Buprenorphine Maintenance Therapy in Patients Suffering from Opioid Dependence orexo.com ↗
Orexo AB (publ) announced today that the U.S. Food and Drug Administration (FDA) has approved ZUBSOLV® (buprenorphine/naloxone CIII sublingual tablet) for induction of buprenorphine maintenance therapy in patients with opioid dependence. |
| 2015-04-22 | Orexo AB | Results New 24-week clinical study strengthens the evidence of the therapeutic value of Zubsolv® for maintenance treatment of opioid dependence orexo.com ↗
The results establish that Zubsolv is effective, well tolerated and demonstrated a safety profile consistent with the product labeling for sublingual buprenorphine products. |
| 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. |
| 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. |
| 2010-12-14 | Orexo AB | Results Orexo reports phase I trial results for OX219, a novel sublingual tablet formulation for the treatment of opioid dependence orexo.com ↗
In the comparative bioavailability study, the OX219 buprenorphine/naloxone sublingual tablet formulation demonstrated favourable profiles compared to the comparator Suboxone®, which is the market leading product for treatment of opioid dependence. |
All press releases naming this drug 6 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 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01848054 ↗ |
| Known as | BNX | “The purpose of the study was to assess the efficacy of induction treatment with buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with...” NCT01848054 ↗ |