A Phase 2, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety, Efficacy, and Pharmacokinetics of N1539 Following Bunionectomy

Trial Profile

A Phase 2, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety, Efficacy, and Pharmacokinetics of N1539 Following Bunionectomy

Completed
Phase of Trial: Phase II

Latest Information Update: 28 Sep 2017

At a glance

  • Drugs Meloxicam (Primary)
  • Indications Postoperative pain
  • Focus Adverse reactions
  • Sponsors Recro Pharma
  • Most Recent Events

    • 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.
    • 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.
    • 07 Sep 2016 Data from this trial will be presented at PAINWeek, the National Conference on Pain for Frontline Practitioners, according to a Recro Pharma media release.
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