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: 16 Apr 2018

At a glance

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

    • 16 Apr 2018 According to a Recro Pharma media release, data from this trial will be presented at the 43rd Annual Regional Anesthesiology and Acute Pain Medicine Meeting co-hosted by the American Society of Regional Anesthesia and Pain Medicine (ASRA).
    • 27 Feb 2018 According to a Recro Pharma media release, the New Drug Application (NDA) for intravenous (IV) meloxicam 30mg for the treatment of moderate to severe, acute postoperative pain has been accepted by the FDA in October 2017 and the FDA has assigned a PDUFA date of 26 May 2018.
    • 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.
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