Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management votes 18-1 to approve investigational once-monthly injectable buprenorphine formulation.
The Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US FDA voted 18 to 1 to recommend approval of Indivior's RBP-6000 for the treatment of opioid use disorder (OUD), according to a statement from the company.
RBP-6000 is an investigational once-monthly injectable buprenorphine formulation in the Atrigel delivery system for the treatment of adults with moderate-to-severe OUD, as part of a complete treatment plan to include counseling and psychosocial support.
The FDA will consider the Advisory Committees’ non-binding recommendation in its review of the New Drug Application for RBP-6000 that was submitted by Indivior on May 30, 2017. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2017.