Phase III clinical trial of RBP 6000 (buprenorphine monthly depot) meets primary endpoint for opioid use disorder- Indivior

Indivior has announced positive top-line results of the pivotal Phase III clinical trial of RBP 6000 (buprenorphine monthly depot) an investigational new drug for the treatment of opioid use disorder as part of a complete treatment plan to include counseling and psychosocial support. These results bring the potentially transformational drug one step closer to market, further bolstering the Company's efforts to pioneer life-transforming treatments for people suffering with opioid use disorder. Indivior remains on track to complete the data analysis of this Phase III trial as well as the open-label long-term assessment of the safety and tolerability of RBP 6000 by Q1 2017 in line with previous guidance. Subject to satisfactory completion of the analysis and, assuming the FDA review and approval is achieved within the assumed six month Priority Review timeline, it is possible that a marketing authorization could be granted in Q4 2017 per previous guidance.

The primary objective of this study was to assess the efficacy of monthly SC injections of RBP6000 in two dosing regimens containing either 300 mg buprenorphine for six injections, or 300 mg for two injections followed by 100 mg buprenorphine for four injections, compared with placebo over a six-month dosing period in subjects not currently in treatment but seeking medication-assisted treatment for opioid use disorder. In this study, RBP-6000 achieved the primary endpoint of the cumulative distribution function (CDF) of the percentage of urine samples negative for opioids combined with self-reports negative for illicit opioid use collected from week 5 through week 24. The key secondary endpoint in this study was treatment success defined as any subject with more than 80% of urine samples negative for opioids combined with self-reports negative for illicit opioid use from week 5 through week 24. The secondary endpoint was also achieved for both dosage regimens.

RBP 6000 was generally well tolerated in this study. Available safety findings suggest that 2.8% of subjects on RBP-6000 (both dosage regimens combined) experienced a serious treatment-emergent adverse event (TEAE) compared with 5.1% of subjects on placebo. There were no related serious TEAEs across groups.