A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain

Trial Profile

A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Aug 2017

At a glance

  • Drugs Sufentanil (Primary) ; Morphine
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors AcelRx Pharmaceuticals
  • Most Recent Events

    • 01 Aug 2017 According to an AcelRx Pharmaceuticals media release, the company intends to submit results from IAP312 study together with results of phase 3 studies (IAP309, IAP310 and IAP311) as part of resubmission of a New Drug Application to the FDA by the end of 2017.
    • 23 Sep 2015 According to a Grunenthal media release, the European Commission has granted marketing authorization for Zalviso for treatment of acute moderate to severe post-operative pain in adult patients.
    • 03 Aug 2015 AcelRx Pharmaceuticals has been granted a General Advice meeting with the U.S. FDA in early September to discuss the FDA's request for a clinical trial and the company's planned response to the Complete Response Letter issued by the FDA for the NDA for Zalviso.
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