Apple Tree Partners

Prescription Drug User Fee Act (PDUFA) action date set for May 23, 2023

Plymouth Meeting, Pa – December 8, 2022 – Braeburn announces that the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly injections for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was accepted by the U S Food and Drug Administration (FDA) The PDUFA action date is set for May 23, 2023

About BRIXADI (buprenorphine) Extended-Release Injection for SC Use (CIII) 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 BRIXADI 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

Braeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder At Braeburn, we challenge the status quo and champion transformation of the management of opioid use disorder (OUD) by partnering with the community to help create a world where every person with OUD gets the best possible care and opportunity to reach their full potential Visit https://braeburnrx com to learn more Connect with Braeburn on LinkedIn at https://linkedin com/company/Braeburn

For additional information, please contact: