Posted by Michael Wonder on 19 Sep 2017
FDA acceptance of NDA for CAM2038 for opioid use disorder
18 September 2017 - The FDA has assigned a Prescription Drug User Fee Act target date of 19 January 2018.
Braeburn Pharmaceuticals announces that the U.S. FDA has accepted its new drug application with priority review designation for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder.
The application for CAM2038, which was submitted on 19 July 2017, comprises data from five Phase 1-2 clinical trials as well as two Phase 3 trials.
