A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety of N1539 Following Major Surgery

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety of N1539 Following Major Surgery

Completed
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2017

At a glance

  • Drugs Meloxicam (Primary)
  • Indications Postoperative pain
  • Focus Adverse reactions
  • 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.
    • 09 May 2017 Status changed from active, no longer recruiting to completed, as reported in a Recro Pharma media release
    • 09 May 2017 According to a Recro Pharma media release, based on the data from this and other two Phase III trials (see profile 255108 and 262380) along with the data from Phase II trials and other safety studies, the company is planning to file NDA with U.S. FDA for IV meloxicam 30mg for management of moderate to severe pain during early Q3 2017.
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