Posted by Michael Wonder on 22 Jan 2018
Braeburn receives complete response letter for CAM2038 injectable buprenorphine depot for the treatment of opioid use disorder
21 January 2018 - Braeburn Pharmaceuticals today announced that it has received a complete response letter from the U.S. FDA regarding the new drug application for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder.
The FDA has requested additional information in order to progress the application forward. There is no need for additional clinical studies and the Agency's requests will be addressed in a timely manner.
CAM2038 was previously granted fast track and priority review designations by the FDA. If approved, CAM2038 would be the first and only injectable for opiate use disorder that can be administered by healthcare professionals from Day 1 of a patient's treatment.
