FDA panel recommends some doses of CAM2038

A joint meeting of FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee recommended approval of some doses of CAM2038 from Braeburn Pharmaceuticals Inc. (Princeton, N.J.) by a 17-3 vote. The product is a ready-to-use prefilled syringe containing a lipid solution of buprenorphine with Camurus' FluidCrystal injection depot technology.

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. Braeburn spokesperson Nancy Leone told BioCentury the committees did not vote on whether specific dose levels should be approved (see BioCentury, Sept. 22)...