FDA again reviewing Braeburn's opioid addiction candidate

Braeburn Pharmaceuticals Inc. (Princeton, N.J.) said FDA accepted and granted Priority Review to a resubmitted NDA for CAM2038 to treat opioid use disorder. The candidate, a ready-to-use prefilled syringe containing a lipid solution of buprenorphine, has a PDUFA date of Dec. 26.

In January, the agency issued a complete response letter for CAM2038. FDA requested additional data but did not require further clinical trials...