> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA OK’s New Opioid Use Disorder Option
- URL: https://www.fdaweb.com/fda-oks-new-opioid-use-disorder-option/
- Published: 2023-05-23T12:00:00.000Z
- Updated: 2026-09-14T18:33:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154517

FDA has approved a Braeburn Inc. NDA for [Brixadi (buprenorphine)](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmFjY2Vzc2RhdGEuZmRhLmdvdi9kcnVnc2F0ZmRhX2RvY3MvbGFiZWwvMjAyMy8yMTAxMzZPcmlnMXMwMDBsYmwucGRmP3V0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSIsImJ1bGxldGluX2lkIjoiMjAyMzA1MjMuNzcxODA3NDEifQ.i9fCEKUYqCJoY%5F1lYkkFxqiKCFGZ-I6aZntlCc1xB-I/s/1255931999/br/203595733672-l?ref=fdaweb.com) extended-release injection (subcutaneous) for treating moderate to severe opioid use disorder. Brixadi comes in two formulations — a weekly injection for patients who have just started treatment, and a monthly version for patients already being treated with buprenorphine. An [FDA release](https://www.fda.gov/news-events/press-announcements/fda-approves-new-buprenorphine-treatment-option-opioid-use-disorder?ref=fdaweb.com) says Brixadi will be available through a Risk Evaluation and Mitigation Strategy program and administered only by health care providers in a health care setting.

The most common adverse reactions (occurring in more than 5% of patients) with Brixadi include injection-site pain, headache, constipation, nausea, injection-site erythema, itchy skin at the injection site, insomnia and urinary tract infections.