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A Phase 3, Single-arm Study Evaluating the Safety and Effectiveness of VX-548 for Acute Pain

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Trial Profile

A Phase 3, Single-arm Study Evaluating the Safety and Effectiveness of VX-548 for Acute Pain

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Oct 2024

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At a glance

  • Drugs Suzetrigine (Primary)
  • Indications Acute pain; Postoperative pain
  • Focus Adverse reactions
  • Sponsors Vertex Pharmaceuticals

Most Recent Events

  • 18 Oct 2024 According to a Vertex pharmaceuticals media release, the company will present data from this study at the annual meeting of the American Society of Anesthesiologists (ASA), taking place from October 18-22, 2024 in Philadelphia, Pennsylvania in a poster session on Saturday, October 19, from 10:00-11:30 a.m. ET.
  • 30 Jul 2024 According to a Vertex pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submission for suzetrigin to treat moderate-to-severe acute pain. The FDA has granted suzetrigine priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025.
  • 06 May 2024 According to a Vertex pharmaceuticals media release, FDA has granted a rolling New Drug Application (NDA) submission to suzetrigine in moderate-to-severe acute pain, as company has started the rolling submission process. The submission is on track to be completed in the second quarter of 2024.

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