FDA accepts NDA on re-submission for Brixadi extended-release weekly and monthly subcutaneous injections for moderate to severe opioid use disorder.- Braeburn

Brixadi is an investigational, extended-release SC injectable therapy under review by FDA 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. If approved, Brixadi would be used as part of a complete treatment plan that includes counseling and psychosocial support. Broxadi will be available through a Risk Evaluation and Mitigation Strategy (REMS) program and administered only by healthcare providers in a healthcare setting.

During the clinical development program, the safety profile of Brixadi was generally consistent with the known safety profile of oral buprenorphine with the exception of mild-to-moderate injection-site reactions. The most common adverse reactions (occurring in ?5% of patients) associated with Brixadi administration included injection-site pain, headache, constipation, nausea, injection-site erythema, injection-site pruritus, insomnia and urinary tract infections.