Braeburn announces that today the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was resubmitted to the U.S. Food and Drug Administration (FDA). The resubmission is in response to a Complete Response Letter issued by the FDA in December citing deficiencies found during an inspection at a third-party manufacturing facility.
Braeburn has worked closely with the third-party manufacturer to address the deficiencies identified in the CRL. The CRL did not cite any other deficiencies other than those related to third-party manufacturing. Braeburn expects to receive a PDUFA date in 30 days.
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 protected]