Braeburn Receives Complete Response Letter for the NDA for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

 

Plymouth Meeting, Pa. — December 2, 2020 — Braeburn announces that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection for subcutaneous (SC) use (CIII) for the treatment of moderate to severe opioid use disorder. In the CRL, the FDA stated that it was unable to approve the NDA due to deficiencies found during a recent inspection at a third-party manufacturing facility.

The CRL did not identify any other deficiencies except for those related to third-party manufacturing.  Braeburn is working closely with the third-party manufacturer to quickly address these issues.

“We remain committed to working expeditiously with the FDA to complete the review for BRIXADI as soon as possible,” said Mike Derkacz, President and CEO of Braeburn. “The opioid crisis has been exacerbated by the COVID-19 pandemic, and healthcare professionals and patients need additional treatment options.”

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

If approved, BRIXADI, an extended release weekly (8mg, 16mg, 24mg, 32mg) and monthly (64 mg, 96mg, 128mg) SC injection, will be indicated 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. BRIXADI should 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. BRIXADI was tentatively approved by the FDA in 2018 pending the expiration of an exclusivity period.

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.

About Braeburn

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:

Media Relations:

Colleen Saltmer: csaltmer@braeburnrx.com