Phase 3, Double-Blind, Placebo-Controlled, Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of Buprenorphine HCl Buccal Film in Opioid-Naive Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia

Trial Profile

Phase 3, Double-Blind, Placebo-Controlled, Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of Buprenorphine HCl Buccal Film in Opioid-Naive Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Mar 2017

At a glance

  • Drugs Buprenorphine (Primary)
  • Indications Back pain
  • Focus Registrational; Therapeutic Use
  • Sponsors BioDelivery Sciences International; Endo Pharmaceuticals
  • Most Recent Events

    • 26 Oct 2015 Results presented in Endo Pharmaceuticals media release.
    • 26 Oct 2015 According to Endo Pharmaceuticals media release, the US FDA has approved BELBUCATM (buprenorphine) buccal film for use in patients with chronic pain.
    • 14 May 2015 Results published in an Endo Pharmaceuticals media release.
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