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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Feb 2022

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At a glance

  • Drugs Meloxicam (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Baudax Bio; Recro Pharma

    • Most Recent Events

    • 20 Feb 2020 According to a Baudax Bio media release, U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ANJESO™ (meloxicam injection), which is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics supported by results from this trial.
    • 13 Feb 2020 According to a Baudax Bio media release, the company is working with the U.S. Food and Drug Administration (FDA) for review of the intravenous (IV) meloxicam New Drug Application (NDA), and are currently awaiting the upcoming PDUFA goal date of February 20, 2020
    • 31 Oct 2019 According to a Recro Pharma media release, the Company is now in the process of preparing a comprehensive response to the FDA that includes proposed labeling that aligns with the FDA guidance received in the written decision letter and provides the relevant evidence from the filed NDA to ensure safe and effective use of IV meloxicam by prescribers.
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