A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for the Treatment of Post-Operative Pain in Patients After Abdominal Surgery
Phase of Trial: Phase III
Latest Information Update: 12 Oct 2017
At a glance
- Drugs Sufentanil (Primary)
- Indications Postoperative pain
- Focus Registrational; Therapeutic Use
- Sponsors AcelRx Pharmaceuticals
- 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.
- 08 May 2017 According to an AcelRx Pharmaceuticals media release, results from the study have been published in an open-access journal, Pain Practice.
- 06 Apr 2017 Pooled results from four trials (SAP202, SAP301, SA302 and SAP303) published in an AcelRx Pharmaceuticals media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History