A Multiple Dose Opioid Challenge Study to Assess Blockade of Subjective Opioid Effects of CAM2038 q1w (Buprenorphine FluidCrystal® Subcutaneous Injection Depots) In Adults With Opioid Use Disorder

Trial Profile

A Multiple Dose Opioid Challenge Study to Assess Blockade of Subjective Opioid Effects of CAM2038 q1w (Buprenorphine FluidCrystal® Subcutaneous Injection Depots) In Adults With Opioid Use Disorder

Completed
Phase of Trial: Phase II

Latest Information Update: 20 Jul 2017

At a glance

  • Drugs Buprenorphine (Primary)
  • Indications Opioid abuse
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Sponsors Braeburn Pharmaceuticals; Camurus
  • 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
    • 22 Jun 2017 Results published in a Braeburn Pharmaceuticals media release.
    • 22 Jun 2017 According to a Braeburn Pharmaceuticals media release, new data set were presented at the annual scientific meeting of the College on Problems of Drug Dependence (CPDD) and manuscript published online in JAMA Psychiatry 2017.
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