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# Advisors Back Indivior Opioid Use Disorder Drug
- URL: https://www.fdaweb.com/advisors-back-indivior-opioid-use-disorder-drug/
- Published: 2017-11-01T12:00:00.000Z
- Updated: 2026-09-14T22:59:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140027

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.