Braeburn gains tentative FDA approval of Brixadi

Braeburn Pharmaceutical (Nasdaq: BBRX) announced on Sunday that the US Food and Drug Administration has granted tentative approval of Brixadi (buprenorphine; CAM2038) extended-release weekly injections.

The tentative approval is for use of Brixadi for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. Brixadi is administered only by healthcare providers (HCPs) in a healthcare setting and used as part of a complete treatment program that includes counseling and psychosocial support.

With tentative approval, FDA has concluded that Brixadi, which was developed by Swedish drugmaker Camurus (STO: CAMX), has met all required quality, safety and efficacy standards necessary for approval, but is not eligible for marketing in the USA because of exclusivity considerations.