A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Adaptive Design, Single-Dose Study of Intravenous N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery.
Phase of Trial: Phase II
Latest Information Update: 27 Feb 2018
At a glance
- Drugs Meloxicam (Primary) ; Ibuprofen
- Indications Dental pain; Postoperative pain
- Focus Therapeutic Use
- Sponsors Alkermes plc
- 27 Feb 2018 According to a Recro Pharma media release, the New Drug Application (NDA) for intravenous (IV) meloxicam 30mg for the treatment of moderate to severe, acute postoperative pain has been accepted by the FDA in October 2017 and the FDA has assigned a PDUFA date of 26 May 2018.
- 17 Jan 2018 Results presented in a Recro Pharma media release.
- 12 Jan 2018 Results published in the Journal of Clinical Pharmacology
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History