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ARTICLE | Company News

FDA again reviewing Braeburn's opioid addiction candidate

July 16, 2018 5:23 PM UTC

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...