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

Completed
Phase of Trial: Phase III

Latest Information Update: 09 Nov 2017

At a glance

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

    • 09 Nov 2017 According to an AcelRx Pharmaceuticals media release, results of this trial is presented at American Journal of Emergency Medicine on Nov 2017.
    • 31 Oct 2017 Results assessing feasibility of using SST 30 mcg for moderate-to-severe pain management in the emergency department, were published in the American Journal of Emergency Medicine.
    • 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.
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