Braeburn announced that the Food and Drug Administration (FDA) has tentatively approved Brixadi (buprenorphine) extended-release weekly and monthly injections 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. The product is administered only by healthcare providers in a healthcare setting and used as part of a complete treatment program that includes counseling and psychosocial support. 

Brixadi utilizes FluidCrystal Injection Depot Technology; once in contact with fluids in the tissue, the solution turns into a nanostructured liquid-crystalline gel allowing for slow release of buprenorphine at a steady rate over 1 week or 1 month. In a Phase 3 safety and efficacy trial, Brixadi met the primary endpoint of noninferiority for responder rate vs daily sublingual buprenorphine/naloxone (<.001); a key secondary endpoint, superiority to sublingual buprenorphine/naloxone in the percentage of negative opioid assessments from week 4 to 24, was also met (P =.004). Apart from mild-to-moderate injection site reactions, the safety profile of Brixadi was similar to the known profile of oral buprenorphine.

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“With both weekly and monthly doses, Brixadi supports current treatment guidelines that recommend frequent office visits, especially early in recovery when patients may discontinue treatment and there is a high risk of overdose,” said Mike Derkacz, President and CEO of Braeburn. 

Brixadi will be supplied as weekly (8mg, 16mg, 24mg, 32mg) and monthly (64mg, 96mg, 128mg) injections. The tentative approval means the FDA concluded Brixadi met all the required safety, efficacy, and quality standards necessary for approval, but it is not eligible for marketing at this time due to exclusivity considerations.

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