A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety of N1539 Following Major Surgery
Phase of Trial: Phase III
Latest Information Update: 28 Sep 2017
At a glance
- Drugs Meloxicam (Primary)
- Indications Postoperative pain
- Focus Adverse reactions
- Sponsors Recro Pharma
- 28 Sep 2017 According to a Recro Pharma media release, the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for intravenous (IV) meloxicam 30mg for the management of moderate to severe pain.
- 05 Sep 2017 According to a Recro Pharma media release, results from this trial will be presented at PAINWeek 2017.
- 31 Jul 2017 According to a company media release, lRecro Pharma has submitted an NDA to the US FDA for intravenous (IV) meloxicam 30mg for the treatment of moderate to severe, acute postoperative pain. The NDA is supported by positive results from two pivotal Phase III clinical efficacy trials in patients following bunionectomy and abdominoplasty surgeries, a large double-blind Phase III safety trial and four Phase II clinical trials for the management of moderate to severe postoperative pain.