A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of a Sublingual Sufentanil Tablet 30 mcg for the Treatment of Acute Pain in Patients in Emergency Room Setting

Trial Profile

A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of a Sublingual Sufentanil Tablet 30 mcg for the Treatment of Acute Pain in Patients in Emergency Room Setting

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Oct 2017

At a glance

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

    • 12 Oct 2017 According to an AcelRx Pharmaceuticals media release, the company received a Complete Response Letter (CRL) from the FDA regarding its NDA for DSUVIA. The CRL states that the FDA determined it cannot approve the NDA in its present form and provides recommendations needed for resubmission.
    • 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.
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