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: 06 Apr 2017

At a glance

  • Drugs Sufentanil (Primary)
  • Indications Acute pain
  • Focus Registrational; 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top