FDA Accepts Braeburn's New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
PLYMOUTH MEETING, Pa., Dec. 8, 2022 /PRNewswire/ -- 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.
- PLYMOUTH MEETING, Pa., Dec. 8, 2022 /PRNewswire/ -- 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).
- 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.
- Braeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder.