A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain

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

The purpose of this study is to evaluate the safety and effectiveness of VX-548 in treating acute pain.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Suzetrigine

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials
    • Bakersfield, California, United States, 93301
      • Trovare Clinical Research | Bakersfield, CA
  • Florida
    • Miami, Florida, United States, 33166
      • Mart Medical Research Group LLC
    • South Miami, Florida, United States, 33143
      • Mart Medical Research Group LLC
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research | Atlanta, GA
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Cypress Surgery Center
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • OrthoNebraska Hospital
  • Oklahoma
    • Jenks, Oklahoma, United States, 74037
      • Center for Orthopaedic Reconstruction and Excellence
  • Texas
    • Bellaire, Texas, United States, 77401
      • HD Research LLC | First Surgical Hospital
    • Carrollton, Texas, United States, 75006
      • HD Research LLC | Legent Orthopedic Hospital
    • Houston, Texas, United States, 77380
      • Renovatio Clinical
    • McAllen, Texas, United States, 78501
      • Futuro Clinical Trials
    • San Antonio, Texas, United States, 78258
      • South Texas Spine & Surgical Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Body mass index (BMI) of greater than or equal to (≥) 18.0 to less than (<) 40.0 kilogram per meter square (kg/m^2)
• Non-surgical participants with pain of new origin (not related to a prior known condition) that is moderate or severe on the verbal categorical rating scale (VRS) and ≥4 on the numeric pain rating scale (NPRS)
• Surgical participants reporting pain at the surgical site that is moderate or severe on the VRS and ≥4 on the NPRS

Key Exclusion Criteria:

• Surgical participants:

  • History of previous surgery due to the same condition, except for procedures for which a previous surgery on the contra-lateral limb or organ is allowed
  • History of a prior surgical procedure in the same region of the body that resulted in any perioperative complications or that, in the opinion of the investigator or medical monitor, would preclude participation in the study
• History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suzetrigine (SUZ); Participants received SUZ 100 milligram (mg) as first dose, followed by SUZ 50 mg every 12 hours (q12h) for 14 days or until pain resolves, whichever occurs first.	Drug: Suzetrigine; Tablets for oral administration.; Other Names: VX-548; SUZ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Day 1 up to Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) Scale	The PGA is a single-item assessment of patient perceptions of the method of pain control with the study drug and is evaluated on a 5-point Likert scale as: (poor, fair, good, very good or excellent). Percentage of participants who reported good, very good or excellent on the PGA scale was reported.	Day 14 or at Pain Resolution, whichever occurs first

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): December 12, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: VX22-548-107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No