FDA advisory panel recommends another opioid use disorder drug

Hot on the heels of a similar recommendation for Indivior’s (LSE: INDV) RBP-6000, the US Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 recommending approval of CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD), from privately-held US drugmaker Braeburn Pharmaceuticals.

"The panel's recommendation in favor of CAM2038 brings us another step closer to providing an individualized treatment option to support OUD patients from day one of their recovery, through initiation, to longer-term maintenance therapy," said Mike Derkacz, president and chief executive of Braeburn."

The FDA asked the Committees to vote on recommended approval of all, some or none of the proposed doses of CAM2038, The Committees voted 17 in favor of approval of some of the proposed doses and three in favor of none of the proposed doses of CAM2038.