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: 01 Nov 2017

At a glance

  • Drugs Buprenorphine (Primary)
  • Indications Opioid abuse
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Sponsors Braeburn Pharmaceuticals; Camurus
  • Most Recent Events

    • 01 Nov 2017 According to a Camurus media release, the US Food and Drug Administrations (FDA) Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 recommending approval of CAM2038.
    • 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.
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