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# FDA Nixes Braeburn Opioid Disorder Drug
- URL: https://www.fdaweb.com/fda-nixes-braeburn-opioid-disorder-drug/
- Published: 2018-01-25T12:00:00.000Z
- Updated: 2026-09-14T23:17:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140598

FDA has issued Braeburn Pharmaceuticals a complete response letter on an NDA for CAM2038, an investigational buprenorphine weekly and monthly depot injection for treating adults with opioid use disorder (OUD). In the letter, the agency requested additional information before approval could be considered. The company says the agency did not request additional clinical studies and the letter’s requests will be addressed in a timely manner.

CAM2038 was previously granted FDA fast track and priority review designations. If approved, it would be the first and only injectable for OUD that can be administered by healthcare professionals from Day 1 of a patient’s OUD treatment, Braeburn says.