A Randomized Double-Blind, Placebo- and Active-Controlled, Dose-Ranging Study to Evaluate the Analgesic, Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Open Abdominal Hysterectomy.

Trial Profile

A Randomized Double-Blind, Placebo- and Active-Controlled, Dose-Ranging Study to Evaluate the Analgesic, Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Open Abdominal Hysterectomy.

Completed
Phase of Trial: Phase II

Latest Information Update: 27 Feb 2018

At a glance

  • Drugs Meloxicam (Primary) ; Morphine
  • Indications Postoperative pain
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Alkermes plc
  • Most Recent Events

    • 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.
    • 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.
    • 14 May 2016 Results presented at the 35th Annual Scientific Meeting of the American Pain Society
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