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

NCT05661734 | Completed Phase 3 Results FDA Drug

• 1 other identifier: VX22-548-107
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) Scale

  Day 14 or at Pain Resolution, whichever occurs first

Study Arms (1)

Suzetrigine (SUZ)

EXPERIMENTAL

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

Interventions

Suzetrigine DRUG

Tablets for oral administration.

Also known as: VX-548, SUZ

Suzetrigine (SUZ)

Eligibility Criteria

• Age: 18 Years - 80 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 (\<) 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (14)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Trovare Clinical Research | Bakersfield, CA

Bakersfield, California, 93301, United States

Location

Mart Medical Research Group LLC

Miami, Florida, 33166, United States

Location

Mart Medical Research Group LLC

South Miami, Florida, 33143, United States

Location

Atlanta Center for Medical Research | Atlanta, GA

Atlanta, Georgia, 30331, United States

Location

Cypress Surgery Center

Wichita, Kansas, 67226, United States

Location

OrthoNebraska Hospital

Omaha, Nebraska, 68144, United States

Location

Center for Orthopaedic Reconstruction and Excellence

Jenks, Oklahoma, 74037, United States

Location

HD Research LLC | First Surgical Hospital

Bellaire, Texas, 77401, United States

Location

HD Research LLC | Legent Orthopedic Hospital

Carrollton, Texas, 75006, United States

Location

Renovatio Clinical

Houston, Texas, 77380, United States

Location

Futuro Clinical Trials

McAllen, Texas, 78501, United States

Location

South Texas Spine & Surgical Hospital

San Antonio, Texas, 78258, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Related Publications (1)

• McCoun J, Winkle P, Solanki D, Urban J, Bertoch T, Oswald J, Swisher MW, Taber LA, Healey T, Jazic I, Correll DJ, Negulescu PA, Bozic C, Weiner SG; VX-548-107 Study Team. Suzetrigine, a Non-Opioid NaV1.8 Inhibitor With Broad Applicability for Moderate-to-Severe Acute Pain: A Phase 3 Single-Arm Study for Surgical or Non-Surgical Acute Pain. J Pain Res. 2025 Mar 25;18:1569-1576. doi: 10.2147/JPR.S509144. eCollection 2025.

  PMID: 40165940 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Monitor
• Organization: Vertex Pharmaceuticals Incorporated

medicalinfo@vrtx.com

617-341-6777

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 22, 2022
• Study Start: January 9, 2023
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: July 1, 2025
• Results First Posted: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)