A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain
Phase of Trial: Phase III
Latest Information Update: 16 Nov 2017
At a glance
- Drugs Sufentanil (Primary)
- Indications Postoperative pain
- Focus Registrational; Therapeutic Use
- Sponsors AcelRx Pharmaceuticals
- 16 Nov 2017 According to an AcelRx Pharmaceuticals media release, resuts were published in the journal, Pain 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.
- 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