Phase III trial of RBP 6000 (buprenorphine monthly depot) for adults with moderate-to-severe opioid use disorder meets primary endpoint- Indivior

Indivior announced the presentation of results from its pivotal Phase III clinical trial (RB-US-13-0001) evaluating the efficacy and safety of RBP 6000 (buprenorphine monthly depot) for the treatment of adults with moderate-to-severe opioid use disorder (OUD) as part of a complete treatment plan to include counseling and psychosocial support. The 24-week study met its primary and key secondary endpoints for both dosage regimens of RBP 6000, which demonstrated clinically and statistically significant differences in percentage abstinence and treatment success, defined as any subject with at least 80% of urine samples negative for opioids combined with self-reports negative for illicit opioid use from Weeks 5 to 24, compared to placebo.

In this study, RBP-6000 was generally well tolerated and had a safety profile consistent with that of transmucosal buprenorphine with no unexpected safety findings. Injection site reactions were not treatment-limiting and resulted in less than 1% of subjects discontinuing treatment. The results were presented at the 79th Annual Scientific Meeting of the College on Problems of Drug Dependence (CPDD) meeting.