FDA issues CRL for Braeburn's opioid addiction candidate

Braeburn Pharmaceuticals Inc. (Princeton, N.J.) said Sunday that FDA issued a complete response letter for an NDA for its monthly buprenorphine injection depot CAM2038 to treat opioid use disorder. The company said that FDA requested additional data, but further clinical trials are not needed. Braeburn declined further comment.

This month, Braeburn attracted several new investors in a $110 million mezzanine financing led by Wellington Management Company. Its sole investor to that point had been Apple Tree Partners (see BioCentury Extra, Jan. 10)...