A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Efficacy and Safety of N1539 Following Bunionectomy

Trial Profile

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Efficacy and Safety of N1539 Following Bunionectomy

Completed
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2017

At a glance

  • Drugs Meloxicam (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Recro Pharma
  • Most Recent Events

    • 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.
    • 20 May 2017 Results presented at the 36th Annual Scientific Meeting of the American Pain Society
    • 18 May 2017 According to a Recro Pharma media release, data from this trial presented at the American Pain Society 36th Annual Scientific Meeting 2017.
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