Sensitivity analysis shows Probuphine (subdermal buprenorphine implant) superiority to sublingual buprenorphine in opioid dependence- Braeburn Pharmaceuticals

Braeburn Pharmaceuticals presented data from the Phase III study of Probuphine (subdermal buprenorphine implant) for the long-term maintenance treatment of opioid dependence. The study demonstrates that participants who were clinically stable on sublingual buprenorphine maintained stability when transferred to Probuphine and that they were more likely to sustain abstinence from illicit opioids throughout the six months than participants who remained on sublingual buprenorphine.

Primary efficacy analysis originally presented showed that 96.4 percent of participants in the Probuphine group had at least four months without evidence of drug use versus 87.6 percent in the sublingual buprenorphine group, demonstrating superiority of Probuphine. Additional sensitivity analyses were conducted to support the robustness of the primary analysis, and found a statistically significant difference between Probuphine and sublingual buprenorphine in the proportion of subjects for all 6 months without evidence of illicit opioid use (85.7% versus 71.9%). In addition, imputation of all missing values as positive for illicit opioids also demonstrated significant difference (80.5% versus 67.4%). A more conservative approach, including the use of supplemental sublingual buprenorphine as non-responders as well as imputing all missing values as positive for illicit opioid use, illustrated similar results for Probuphine and sublingual buprenorphine (63.2% versus 53.9%).

The FDA approved Probuphine on May 26, 2016. Data were presented at the 78th Annual Scientific Meeting of The College on Problems of Drug Dependence (CPDD).