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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jul 2024

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At a glance

  • Drugs Buprenorphine (Primary) ; Buprenorphine/naloxone
  • Indications Opioid-related disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Braeburn Pharmaceuticals

Most Recent Events

  • 24 May 2023 According to a Camurus media release, company announces that the US Food and Drug Administration has approved Brixadi (buprenorphine) extended release injection for SC use, a weekly and monthly medication for the treatment of moderate to severe opioid use disorder, in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a daily buprenorphine product, the FDA approval of Brixadi was based this trial.
  • 06 Apr 2019 Results of a post hoc analysis published in the Camurus Media Release
  • 06 Apr 2019 Results presented in a Braeburn Pharmaceuticals media release.

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