23 December 2018 - Brixadi is a long-acting buprenorphine injectable with both weekly and monthly doses to align with the way healthcare providers treat patients with opioid use disorder.

Braeburn today announced that the U.S. FDA has granted tentative approval of Brixadi (buprenorphine) extended-release weekly (8 mg, 16 mg, 24 mg, 32 mg) and monthly (64 mg, 96mg, 128mg) injections. The tentative approval is for use of Brixadi for the treatment of moderate to severe opioid use disorder 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 health care providers in a healthcare setting and used as part of a complete treatment program that includes counselling and psychosocial support.

With tentative approval, FDA has concluded that Brixadi has met all required quality, safety and efficacy standards necessary for approval but is not eligible for marketing in the U.S. because of exclusivity considerations.

Read Braeburn Pharmaceuticals press release