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
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History