A Phase 2, Randomized, Open Label, Multiple-Dose, Comparator, Parallel-Group, Safety and Tolerance Study of Buprenorphine Sublingual Spray (0.5 mg TID) Versus Standard of Care Post-Operative Narcotic Therapy for the Treatment of Post-Operative Pain

Trial Profile

A Phase 2, Randomized, Open Label, Multiple-Dose, Comparator, Parallel-Group, Safety and Tolerance Study of Buprenorphine Sublingual Spray (0.5 mg TID) Versus Standard of Care Post-Operative Narcotic Therapy for the Treatment of Post-Operative Pain

Completed
Phase of Trial: Phase II

Latest Information Update: 06 Dec 2017

At a glance

  • Drugs Buprenorphine (Primary) ; Morphine; Oxycodone
  • Indications Postoperative pain
  • Focus Adverse reactions
  • Sponsors INSYS Therapeutics, Inc
  • Most Recent Events

    • 06 Dec 2017 Status changed from active, no longer recruiting to completed, according to an INSYS Therapeutics, Inc media release.
    • 06 Dec 2017 According to an INSYS Therapeutics, Inc media release, data from this study will be submitted to the FDA in the first quarter of 2018, augmenting the NDA package, and may impact the PDUFA date.
    • 30 Nov 2017 Planned End Date changed from 28 Nov 2017 to 28 Dec 2017.
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