FDA panel recommends some doses of CAM2038

On Wednesday, a joint meeting of FDA's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommended approval of some doses of buprenorphine injection depot (CAM2038) from Braeburn Pharmaceuticals Inc. (Princeton, N.J.) by a vote of 17 to three.

In September, FDA accepted and granted Priority Review to an NDA for CAM2038 to treat opioid use disorder. Its PDUFA date is Jan. 19, 2018. The NDA included once-weekly formulations of 8, 16, 24 and 32 mg and once-monthly formulations of 64, 96, 128 and 160 mg doses of CAM2038. ...