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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Enriched-Enrollment Withdrawal, Multicenter Study to Evaluate the Efficacy and Safety of a Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) in Subjects With Moderate to Severe Chronic Low Back Pain Currently Treated With Daily Opioids

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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Enriched-Enrollment Withdrawal, Multicenter Study to Evaluate the Efficacy and Safety of a Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) in Subjects With Moderate to Severe Chronic Low Back Pain Currently Treated With Daily Opioids

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jun 2023

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At a glance

  • Drugs Buprenorphine (Primary)
  • Indications Back pain
  • Focus Registrational; Therapeutic Use
  • Acronyms CAM2038
  • Sponsors Braeburn Pharmaceuticals

    • Most Recent Events

    • 23 Feb 2023 According to a Camurus media release, the company announced today that it has notified the European Medicines Agency (EMA) of its decision to withdraw the Type II variation application for CAM2038 to include treatment of chronic pain in patients with opioid dependence.
    • 29 Jan 2020 Status changed from active, no longer recruiting to completed.
    • 18 Sep 2018 Results presented in the Camurus media release.

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