Advisors Back Indivior Opioid Use Disorder Drug

Members of the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18-1 on 10/31 to recommend approval of Indivior’s RBP-6000 for treating opioid use disorder. The product is described as an investigational once-monthly injectable buprenorphine formulation in the Atrigel delivery system for treating adults with moderate-to-severe opioid use disorder as part of a complete treatment plan including counseling and psychosocial support.

The company’s NDA was submitted 5/30 and has a PDUFA action date of 11/30. Indivior says the drug met its Phase 3 trial primary efficacy endpoint with two dosage regimens demonstrating abstinence rates that were significantly higher than those achieved by a placebo. The most common adverse reactions reported were constipation, headache, injection site pruritus, vomiting, increased hepatic enzyme, fatigue, and injection site pain.