Opioid use disorder drug RBP-6000 accepted by FDA for priority review

The US Food and Drug Administration has accepted with a Priority Review designation the New Drug Application (NDA) for RBP-6000.

The drug, from UK-based Indivior (LSE: INDV), is an investigational once-monthly injectable buprenorphine in the ATRIGEL delivery system 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 NDA, which was submitted on May 30, 2017, is based on data from the pivotal Phase III study (RBP-US-13-0001) assessing the efficacy and safety of RBP-6000.