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A Multi-Center, Randomized, Double-Blind, Placebo- (Double-Dummy) and Active-Controlled, Parallel-Group Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy

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Trial Profile

A Multi-Center, Randomized, Double-Blind, Placebo- (Double-Dummy) and Active-Controlled, Parallel-Group Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jun 2026

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At a glance

  • Drugs MR-107A-02 (Primary) ; Tramadol
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Mylan Specialty

Most Recent Events

  • 18 May 2026 According to a Viatris media release, data from this study was presented at the PAINWeek 2025.
  • 18 May 2026 According to a Viatris media release, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MR-107A-02 for the treatment of moderate-to-severe acute pain.The FDA has assigned a PDUFA goal date of Dec. 27, 2026.
  • 01 Aug 2025 According to a Viatris media release, data from the trial will be presented at the PAINWeek 2025 national conference in Las Vegas from September 2-5, 2025.

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