The Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for Brixadi (buprenorphine) extended-release weekly and monthly subcutaneous injection 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.
The resubmitted NDA was in response to a Complete Response Letter (CRL) issued by the FDA in December 2021. In the CRL, the FDA stated that the NDA could not be approved in its present form due to continued quality related deficiencies found at a third-party manufacturing facility in the US. There were no other deficiencies noted in the application.
The application includes data from a pivotal phase 3 trial (ClinicalTrials.gov Identifier: NCT02651584) that compared the long-acting subcutaneous treatment to an existing standard of care, sublingual buprenorphine/naloxone, in patients with moderate to severe opioid use disorder. The primary endpoint was the response rate at week 24, defined as at least 33% of urine toxicology results collected during weekly visits and 67% of urine toxicology results collected during monthly visits being negative for illicit opioids and self-reported illicit opioid use.
Results showed that Brixadi met the primary endpoint of noninferiority for responder rate vs daily sublingual buprenorphine/naloxone (P <.001). Treatment with Brixadi also met a key secondary endpoint demonstrating superiority to sublingual buprenorphine/naloxone in the percentage of negative opioid assessments from week 4 to 24 (P =.004). Apart from mild to moderate injection site reactions, the safety profile of Brixadi was found to be similar to the known profile of oral buprenorphine.
A Prescription Drug User Fee Act target date of May 23, 2023 has been set for the application. If approved, Brixadi would be supplied as weekly (8mg, 16mg, 24mg, 32mg) and monthly (64mg, 96mg, 128mg) injections for subcutaneous use and would be used as part of a complete treatment plan to include counseling and psychosocial support. A Risk Evaluation and Mitigation Strategy program would also be established; treatment would be administered only by a health care provider in a health care setting.
- FDA accepts Braeburn’s New Drug Application resubmission for Brixadi™ (buprenorphine) extended-release subcutaneous injection for moderate to severe opioid use disorder. News release. Braeburn. December 8, 2022. Accessed December 9, 2022. https://www.prnewswire.com/news-releases/fda-accepts-braeburns-new-drug-application-resubmission-for-brixadi-buprenorphine-extended-release-subcutaneous-injection-for-moderate-to-severe-opioid-use-disorder-301698779.html.
- Braeburn resubmits New Drug Application for Brixadi™ (buprenorphine) extended-release subcutaneous injection for moderate to severe opioid use disorder. News release. Braeburn. November 23, 2022. Accessed December 9, 2022. https://braeburnrx.com/braeburn-resubmits-new-drug-application-for-brixadi-buprenorphine-extended-release-subcutaneous-injection-for-moderate-to-severe-opioid-use-disorder-2/.