A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain
Phase of Trial: Phase III
Latest Information Update: 01 Aug 2017
At a glance
- Drugs Sufentanil (Primary) ; Morphine
- Indications Postoperative pain
- Focus Registrational; Therapeutic Use
- Sponsors AcelRx Pharmaceuticals
- 01 Aug 2017 According to an AcelRx Pharmaceuticals media release, the company intends to submit results from IAP312 study together with results of phase 3 studies (IAP309, IAP310 and IAP311) as part of resubmission of a New Drug Application to the FDA by the end of 2017.
- 23 Sep 2015 According to a Grunenthal media release, the European Commission has granted marketing authorization for Zalviso for treatment of acute moderate to severe post-operative pain in adult patients.
- 03 Aug 2015 AcelRx Pharmaceuticals has been granted a General Advice meeting with the U.S. FDA in early September to discuss the FDA's request for a clinical trial and the company's planned response to the Complete Response Letter issued by the FDA for the NDA for Zalviso.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History