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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

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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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 18 Aug 2023

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At a glance

  • Drugs Buprenorphine (Primary)
  • Indications Opioid-related disorders
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Sponsors Braeburn Pharmaceuticals; Camurus

Most Recent Events

  • 16 Aug 2023 Results published in the Clinical Pharmacokinetics
  • 16 Jul 2018 According to a Camurus media release, US FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2018 for its investigational weekly and monthly buprenorphine depots, CAM2038, for the treatment of adults with opioid use disorder (OUD).
  • 28 May 2018 According to a Camurus media release, Braeburn has resubmitted the New Drug Application (NDA) for CAM2038 weekly and monthly buprenorphine depot injections to the US Food and Drug Administration (FDA) in response to a Complete Response Letter (CRL) received in January 2018. A notification by the FDA of a Prescription Drug User Fee Act (PDUFA) action date is expected by Braeburn within 30 days.

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