FDA Accepts Braeburn’s New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
Prescription Drug User Fee Act (PDUFA) action date set for December 15, 2021
Plymouth Meeting, Pa. – June 26, 2021 – Braeburn announces that the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was accepted by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) action date is set for December 15, 2021.
“We are pleased that the FDA has accepted our application for BRIXADI,” said Mike Derkacz, President and CEO of Braeburn. “We look forward to working with the FDA to advance BRIXADI toward approval and to providing another option for healthcare providers to treat their patients with opioid use disorder, a disease that continues to have a devastating impact on patients, their loved ones, and communities.”
About BRIXADI (buprenorphine) Extended-Release Injection for SC Use (CIII)
BRIXADI is an investigational, extended-release weekly (8mg, 16mg, 24mg, 32mg) and monthly (64 mg, 96mg, 128mg) injection for subcutaneous use that is 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. Our mission is to advance next-generation therapies, with individualized dosing regimens and delivery options, to address the escalating disease burden of opioid use disorder faced by patients, healthcare professionals, payers and society. For more information about Braeburn, please visit https://braeburnrx.com .
For additional information, please contact:
Colleen Saltmer: email@example.com