Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
Summary
The purpose of this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX sublingual tablets compared with BNX film. Secondary objectives included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and safety.
Timeline
- Start
- 2013-08
- Primary completion
- 2014-04
- Completion
- 2014-04
Outcome
Met primary endpoint
paper Day-3 retention rates were 93.9% (309/329) and 92.6% (302/326) with the BNX tablet and buprenorphine, respectively (between-group difference 95% CI, -2.6 to 5.1). PMID 26412801 ↗
paper Day-15 retention rates were 83.0% (273/329) and 82.5% (269/326) with the BNX tablet and BNX film, respectively (between-group difference 95% CI, -5.3 to 6.3). PMID 26412801 ↗
paper Based on the findings from this study in patients with opioid dependence, the higher-bioavailability BNX sublingual tablet formulation was noninferior to both generic buprenorphine (induction) and BNX film (stabilization). PMID 26412801 ↗
release “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” orexo.com ↗
release “Phase 3 clinical trial demonstrating that Zubsolv® (buprenorphine/naloxone CIII sublingual tablet) is as effective as Suboxone® film in the treatment of opioid dependence.” orexo.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Buprenorphine | Other / unclassified | — | Other |
| Subject | Buprenorphine/naloxone | Unknown | — | Other |
| Subject | Buprenorphine/naloxone | Unknown | — | Other |