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

NCT06887972 | Completed Phase 4 FDA Drug

• 1 other identifier: VX24-548-113
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global assessment (PGA) for Pain Control at the end of Treatment

  From Day 3 up to Day 14

Study Arms (1)

Suzetrigine (SUZ)

EXPERIMENTAL

Participants will receive SUZ for 14 days or until their pain resolves, whichever occurs first.

Drug: Suzetrigine

Interventions

Suzetrigine DRUG

Tablets for oral administration.

Also known as: VX-548, SUZ, JOURNAVX

Suzetrigine (SUZ)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participated in a previous study with SUZ or received Journavx

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (5)

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Beth Israel Deaconess Medical Center - Surgery

Boston, Massachusetts, 02215, United States

Location

HD Research LLC | First Surgical Hospital

Bellaire, Texas, 77401, United States

Location

Memorial Hermann Village

Houston, Texas, 77043, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 21, 2025
• Study Start: March 21, 2025
• Primary Completion: October 24, 2025
• Study Completion: November 7, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)