A Phase 3, Randomized, Double Blind, Multiple Dose, Parallel Group, Placebo Controlled Study of Buprenorphine Sublingual Spray (0.5 mg TID, 0.25 mg TID, and 0.125 mg TID) for the Treatment of Moderate to Severe Pain

Trial Profile

A Phase 3, Randomized, Double Blind, Multiple Dose, Parallel Group, Placebo Controlled Study of Buprenorphine Sublingual Spray (0.5 mg TID, 0.25 mg TID, and 0.125 mg TID) for the Treatment of Moderate to Severe Pain

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Aug 2017

At a glance

  • Drugs Buprenorphine (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors INSYS Therapeutics, Inc
  • Most Recent Events

    • 10 Sep 2016 According to an Insys Therapeutics media release, the company anticipates discussing these results with the FDA and file a New Drug Application by the end 2016.
    • 24 Aug 2016 Results published in Insys Therapeutics media release.
    • 24 Aug 2016 According to an Insys Therapeutics, Inc. media release, primary endpoint, Numeric rating scale (NRS) summed pain intensity difference (SPID) over 0 to 48 hours (NRS SPID 48) after Time 0 safety_issue: No description: NRS SPID is calculated as a time weighted average of pain rated by the participant from 0 to 10 ("no pain" to "worst pain imaginable") time_frame: over 0 to 48 hours after Time 0 has been met.
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