FDA accepts and grants Priority Review to CAM2038 for opioid use disorder

Braeburn Pharmaceuticals Inc. (Princeton, N.J.) said FDA accepted and granted Priority Review to an NDA for weekly and monthly buprenorphine injection depot (CAM2038) to treat opioid use disorder. Its PDUFA date is Jan. 19, 2018.

Braeburn has exclusive, North American rights as well as option rights in Japan, Korea, Taiwan and China to CAM2038 under an expanded 2014 deal with Camurus (see BioCentury, Dec. 8, 2014 & Oct. 31, 2016)...