Complete Response for CAM 2038 a proposed treatment for opioid use disorder.- Braeburn Pharmaceuticals.
Braeburn Pharmaceuticals, Inc.announced that it has received a complete response letter (CRL) from the FDA regarding the new drug application (NDA) for CAM 2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD).
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.
Comment:CAM 2038 was previously granted Fast Track and Priority Review designations by the FDA. If approved, CAM 2038 would be the first and only injectable for opioid use disorder that can be administered by healthcare professionals from Day 1 of a patient�s OUD treatment.
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