‘Tentative’ FDA approval for Braeburn's opioid addiction product

Braeburn Pharmaceuticals Inc. (Plymouth Meeting, Pa.) said FDA granted “tentative” approval to Brixadi buprenorphine (CAM2038) extended-release weekly and monthly injections to treat moderate-to-severe opioid use disorder. The drug is for use in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.

Partner Camurus AB (SSE:CAMX) said final approval is subject to the expiration of an exclusivity period through November 2020 that was granted to opioid use disorder drug Sublocade subcutaneous buprenorphine from Indivior plc (LSE:INDV). Braeburn could seek to limit the scope and duration of Sublocade's exclusivity by challenging it, but the company declined to disclose whether it would do so...