The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2017.
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.