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: 06 Dec 2017

At a glance

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

    • 06 Dec 2017 According to an INSYS Therapeutics, Inc media release, a New Drug Application (NDA) for buprenorphine as a sublingual spray for the management of moderate-to-severe acute pain has been accepted for filing by the U.S. Food and Drug Administration (FDA). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of July 28, 2018 to complete its review of this NDA. The application was based on this study and several pharmacokinetics studies.
    • 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.
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