An Open-Label Multicenter Study Assessing the Long-Term Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injection Depot of Buprenorphine (CAM2038) in Adult Outpatients with Opioid Use Disorder

Trial Profile

An Open-Label Multicenter Study Assessing the Long-Term Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injection Depot of Buprenorphine (CAM2038) in Adult Outpatients with Opioid Use Disorder

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Sep 2017

At a glance

  • Drugs Buprenorphine (Primary)
  • Indications Opioid abuse
  • Focus Adverse reactions; Registrational
  • Sponsors Braeburn Pharmaceuticals
  • Most Recent Events

    • 29 Sep 2017 According to a Camurus media release, the company's Marketing Authorization Application (MAA) for CAM2038 was fully validated by the European Medicines Agency (EMA). The application, submitted on 26 July 2017, is now under assessment by the Committee for Human Medicinal Products (CHMP).
    • 18 Sep 2017 According to a Braeburn Pharmaceuticals media release, the US FDA has accepted the NDA with Priority Review designation for CAM2038 for the treatment of adults with opioid use disorder (OUD). The NDA for CAM2038from five Phase 1-2 clinical trials as well as two Phase 3 trials. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of January 19, 2018.
    • 20 Jul 2017 According to a Braeburn Pharmaceuticals media release,Braeburn Pharmaceuticals and Camurus has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of the companies' weekly and monthly buprenorphine depots (CAM2038) to treat Opioid Use Disorder. Braeburn has also applied for Priority Review which, if granted, could shorten the review process of CAM2038 following the FDA's acceptance of the NDA
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