Braeburn Pharmaceuticals gets priority review for opioid candidate

Braeburn Pharmaceuticals has received priority review designation for CAM2038, a weekly and monthly buprenorphine injection for opioid use disorder (OUD).

The candidate, which is also in Phase III testing as an abuse-resistant pain medication, was submitted to the US regulator with data from Phase I/II clinical trials as well as two Phase III trials.

The company says trials met the primary endpoint of non-inferiority versus treatment with daily sublingual buprenorphine/naloxone, the current standard of care.

The safety profile of CAM2038 was generally consistent with the known safety profile of buprenorphine, with the exception of mild-to-moderate injection-site adverse events.

Chief executive Mike Derkacz said: "Because the weekly and monthly formulations are administered by healthcare professionals and remain in their control, if approved, CAM2038 may help mitigate the inherent risks of daily oral medication in terms of diversion, misuse and pediatric exposure."