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: 31 Jul 2017
At a glance
- Drugs Meloxicam (Primary) ; Ibuprofen
- Indications Dental pain; Postoperative pain
- Focus 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.
- 10 Sep 2015 Results published in Recro Pharma media release.
- 10 Sep 2015 Primary endpoint (Pain intensity difference) has been met as per PAINWeek conference, presented in Recro Pharma media release.