A Single-Arm Study Evaluating the Effectiveness and Safety of Suzetrigine (SUZ) for Acute Pain After Aesthetic or Reconstructive Surgeries

December 5, 2025 updated by: Vertex Pharmaceuticals Incorporated

A Phase 4, Open-label, Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine As Part of Multimodal Therapy for Acute Pain After Aesthetic or Reconstructive Surgeries

The purpose of this study to evaluate the effectiveness, safety, and tolerability of SUZ as part of multimodal therapy (MMT) in treating acute postoperative pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center - Surgery
    • Texas
      • Bellaire, Texas, United States, 77401
        • HD Research LLC | First Surgical Hospital
      • Houston, Texas, United States, 77043
        • Memorial Hermann Village
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • JBR Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • 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 or equal to (≤) 40.0 kilogram per meter square (kg/m^2)
  • Participants scheduled to undergo an aesthetic or reconstructive surgical procedure that would typically be treated with opioid therapy for at least 72 hours postoperatively

Key Exclusion Criteria:

• Participated in a previous study with SUZ or received Journavx

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suzetrigine (SUZ)
Participants will receive SUZ for 14 days or until their pain resolves, whichever occurs first.
Drug: Suzetrigine
Tablets for oral administration.
Other Names:
  • VX-548
  • SUZ
  • JOURNAVX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global assessment (PGA) for Pain Control at the end of Treatment
Time Frame: From Day 3 up to Day 14
From Day 3 up to Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2025

Primary Completion (Actual)

October 24, 2025

Study Completion (Actual)

November 7, 2025

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 21, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX24-548-113

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/our-science/clinical-trials-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

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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