A Randomized Double-Blind, Placebo- and Active-Controlled, Dose-Ranging Study to Evaluate the Analgesic, Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Open Abdominal Hysterectomy.
Phase of Trial: Phase II
Latest Information Update: 31 Jul 2017
At a glance
- Drugs Meloxicam (Primary) ; Morphine
- Indications Postoperative pain
- Focus Adverse reactions; Therapeutic Use
- Sponsors Alkermes plc
- 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.
- 14 May 2016 Results presented at the 35th Annual Scientific Meeting of the American Pain Society
- 12 May 2016 Results published at the American Pain Society's 35th Annual Scientific Meeting, as per Recro Pharma media release.