Braeburn announces that today the New Drug Application (NDA) for BRIXADI was resubmitted to the U.S. Food and Drug Administration (FDA).
PLYMOUTH MEETING, Pa., June 15, 2021 /PRNewswire/ -- 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) 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 For additional information, please contact: View original content to download multimedia:http://www.prnewswire.com/news-releases/braeburn-resubmits-new-drug-application-for-brixadi-buprenorphine-extended-release-subcutaneous-injection-for-moderate-to-severe-opioid-use-disorder-301313130.html SOURCE Braeburn |