A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel Group, Multi-center Trial Assessing the Efficacy and Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) in Treatment of Adult Outpatients With Opioid Use Disorder

Trial Profile

A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel Group, Multi-center Trial Assessing the Efficacy and Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) in Treatment of Adult Outpatients With Opioid Use Disorder

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jul 2017

At a glance

  • Drugs Buprenorphine (Primary) ; Buprenorphine/naloxone
  • Indications Opioid abuse
  • Focus Registrational; Therapeutic Use
  • Sponsors Braeburn Pharmaceuticals
  • Most Recent Events

    • 20 Jul 2017 According to a Braeburn Pharmaceuticals and Camurus media release, in June 2017, the highlights of the data was presented at the annual scientific meeting of the College on Problems of Drug Dependence (CPDD)
    • 20 Jul 2017 According to a Braeburn Pharmaceuticals and Camurus media release, full results from the study will be presented in a scientific publication.
    • 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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