Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy

Trial Profile

Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy

Completed
Phase of Trial: Phase II

Latest Information Update: 06 Apr 2017

At a glance

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

    • 06 Apr 2017 Pooled results from four trials (SAP202, SAP301, SA302 and SAP303) published in an AcelRx Pharmaceuticals media release.
    • 06 Apr 2017 Pooled results from four trials (SAP202, SAP301, SA302 and SAP303) will be presented as an e-poster at the 2017 Annual Regional Anesthesiology and Acute Pain Medicine Meeting, according to an AcelRx Pharmaceuticals media release.
    • 27 Feb 2017 According to an AcelRx Pharmaceuticals media release, the U.S. FDA has accepted NDA under section 505(b)(2) for DSUVIA™ (sufentanil sublingual tablet, 30 mcg) for the treatment of patients with moderate-to-severe acute pain in a medically supervised setting, based on the data from SAP301, SAP202, SAP302 and SAP303 trials. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of October 12, 2017. The FDA is planning an Advisory Committee meeting to review the DSUVIA application.
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