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: 20 Jul 2017

At a glance

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

    • 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
    • 02 May 2017 Camurus and Braeburn Pharmaceuticals expect to make regulatory submissions to EMA and FDA in mid-2017, according to a company media release.
    • 02 May 2017 Top-line results published in a Camurus media release.
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