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 | “Orexo AB (publ) announces today that it has submitted an application to the U.S. Food and Drug Administration (FDA) for an expanded label of ZUBSOLV (buprenorphine/naloxone...” orexo.com ↗ “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 3 | NCT01908842 | Aug 2013 → Apr 2014 | opiate dependence | Orexo AB | Completed | Met primary |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2023-10-11 | Orexo AB | Results Orexo announces data from the MODIA® study evaluating impact on use of illicit opioids orexo.com ↗
The study had unexpectedly high treatment response rates for both treatment arms, with no statistically significant difference in treatment response in the full population. |
| 2016-10-06 | Orexo AB | Regulatory FDA Approves Unique Low Dosage of Zubsolv® orexo.com ↗
Orexo AB (publ.) announced today that it has received approval from the US Food and Drug Administration (FDA) of a new unique low dose, 0.7mg/0.18 mg, tablet of Zubsolv (buprenorphine/naloxone) sublingual tablet (CIII) for the treatment of opioid dependence. |
| 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. |
| 2015-06-10 | Orexo AB | Regulatory FDA approves the medium tablet strength, 2.9 mg/0.71 mg, of ZUBSOLV® orexo.com ↗
Orexo AB (publ) announces today that it has received approval from the U.S. Food and Drug Administration (FDA) of medium dosage strength of ZUBSOLV® (buprenorphine/naloxone CIII sublingual tablet) for maintenance treatment of opioid dependence. |
| 2015-04-23 | Orexo AB | Results Interim report January-March 2015 orexo.com ↗
New clinical data establish Zubsolv as effective, well tolerated for maintenance treatment of opioid dependence and increases patients’ work productivity. |
| 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. |
| 2014-12-12 | Orexo AB | Regulatory FDA approves two higher dosage strengths of ZUBSOLV® orexo.com ↗
Orexo AB (publ) announces today that it has received approval from the U.S. Food and Drug Administration (FDA) of two higher dosage strengths of ZUBSOLV (buprenorphine/naloxone CIII sublingual tablet) for maintenance treatment of opioid dependence. |
| 2014-10-13 | Orexo AB | Regulatory Orexo submits application to FDA for expanded label of ZUBSOLV® orexo.com ↗
Orexo AB (publ) announces today that it has submitted an application to the U.S. Food and Drug Administration (FDA) for an expanded label of ZUBSOLV (buprenorphine/naloxone CIII sublingual tablet) to include initiation of treatment for opioid dependence. |
| 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. |
| 2013-07-04 | Orexo AB | Regulatory FDA Approves Zubsolv™ for the Maintenance Treatment of Opioid Dependence orexo.com ↗
Orexo today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for Zubsolv™ (buprenorphine/naloxone) sublingual tablet CIII. |
| 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 12 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Buprenorphine/naloxone | “Buprenorphine/naloxone sublingual film” NCT01908842 ↗ |