A Multicenter, Open-Label Trial to Evaluate the Overall Performance of the Zalviso System (Sufentanil Sublingual Tablet System) 15 mcg

Trial Profile

A Multicenter, Open-Label Trial to Evaluate the Overall Performance of the Zalviso System (Sufentanil Sublingual Tablet System) 15 mcg

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Aug 2017

At a glance

  • Drugs Sufentanil (Primary)
  • 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 this trial together with results of earlier phase 3 studies (IAP309, IAP310 and IAP311) as part of resubmission of a New Drug Application to the FDA by the end of 2017.
    • 01 Aug 2017 Primary endpoint (Device Functionality) has been met, according to results published in an AcelRx Pharmaceuticals Media Release.
    • 01 Aug 2017 Status changed from active, no longer recruiting to completed, according an AcelRx Pharmaceuticals Media Release.
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