FDA Advisory Committees Reach Decision on Opioid Use Disorder Tx
The Food and Drug Administration (FDA)'s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18 to 1 to recommend the approval of RBP-6000 (Indivior), a treatment for opioid use disorder (OUD).
RBP-6000 is a once-monthly injectable buprenorphine sustained-release formulation which uses the Atrigel delivery system. The investigational treatment is intended for adults with moderate-to-severe OUD as part of a complete treatment plan that includes counseling and psychosocial support.
The Atrigel delivery system consists of a polymeric solution of a biodegradable poly-(DL-lactide-co-glycolide) co-polymer dissolved in N-methyl pyrrolidone (NMP), a water-miscible biocompatible solvent. Following injection, NMP diffuses out of the polymer matrix and the polymer precipitates, trapping buprenorphine inside and forming an amorphous solid depot in situ. Then over a 1-month period, the depot releases buprenorphine by diffusion as the polymer degrades.
A Phase 3 study found that 300mg/300mg and 300mg/100mg doses of RBP-6000 had significantly greater abstinence rates when compared with placebo (41.3% and 42.7% vs. 5.0%; P<0.0001). Its safety profile was consistent with that observed with transmucosal buprenorphine except for injection site reactions.
The FDA will now consider the Advisory Committees' recommendation as part of its review of the RBP-6000 New Drug Application, submitted on May 30. A Prescription Drug User Fee Act (PDUFA) target action date has been set for November 30, 2017.
For more information visit Indivior.com.