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. – 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.
Posted: July 2021
- Braeburn Submits Request for Final Approval of Brixadi (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder – June 1, 2020
- FDA Grants Braeburn’s Citizen Petition Allowing Brixadi (buprenorphine) Extended-Release Injection for Opioid Use Disorder to be Available in December 2020 – November 7, 2019
- Braeburn Announces Tentative FDA Approval of Brixadi (buprenorphine) Extended-Release Injection for the Treatment of Moderate to Severe Opioid Use Disorder – December 23, 2018
- Camurus Announces PDUFA Date for CAM2038 for the Treatment of Opioid Use Disorder – July 16, 2018
- Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder – May 28, 2018
- Braeburn Receives Complete Response Letter for CAM2038 Injectable Buprenorphine Depot – January 21, 2018
- Braeburn Announces FDA Advisory Committee Recommends Approval of CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder – November 1, 2017
- Camurus Announces that FDA Grants Priority Review of NDA for Weekly and Monthly CAM2038 Buprenorphine Depots for Treatment of Opioid Use Disorder – September 18, 2017
- Camurus and Braeburn Announce Submission of NDA for Long-Acting Buprenorphine (CAM2038) for Opioid Use Disorder – July 20, 2017
Brixadi (buprenorphine) FDA Approval History
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