23 Nov Braeburn Resubmits New Drug Application for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
Plymouth Meeting, Pa.—November 23, 2022—Braeburn announces that the company has resubmitted to the U.S. Food and Drug Administration (FDA) its New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder. The resubmission is in response to a Complete Response Letter issued by the FDA in December which cited deficiencies at a third-party manufacturing facility. Braeburn expects to receive a target action date in 30 days.
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 to include 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 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:
Colleen Saltmer: firstname.lastname@example.org