Braeburn completes rolling NDA for CAM2038

Braeburn Pharmaceuticals Inc. (Princeton, N.J.) completed submission of a rolling NDA to FDA for weekly and monthly buprenorphine injection depot (CAM2038) to treat opioid use disorder. The company is seeking Priority Review for the NDA.

Last year, Braeburn and partner Camurus AB (SSE:CAMX) reported Phase III data showing that subcutaneous CAM2038 met FDA- and EMA-defined primary endpoints of non-inferiority to once-daily standard of care (SOC) sublingual buprenorphine/naloxone (see BioCentury, Jan. 9)...