Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

NCT05553366 | Completed Phase 3 Results FDA Drug

• 1 other identifier: VX22-548-104
• Study Type: interventional
• Target: 1,075
• Locations: 1 country
• Sites: 21

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of suzetrigine for acute pain after a bunionectomy.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48), SUZ Compared to Placebo

  SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated subtracting the baseline pain intensity score from the pain intensity score at each postdose time point (using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).

  0 to 48 hours After First Dose of Study Drug

Secondary Outcomes (10)

• Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48), SUZ Compared to HB/APAP

  0 to 48 hours After First Dose of Study Drug

• Time to Greater Than or Equal to (≥)2-Point Reduction in NPRS,SUZ Compared to Placebo

  From Baseline Up to 48 Hours After First Dose of Study Drug

• Time to ≥1-Point Reduction in NPRS, SUZ Compared to Placebo

  From Baseline Up to 48 Hours After First Dose of Study Drug

• Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo

  At 48 Hours After First Dose of Study Drug

• Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP

  From Baseline up to Day 19

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants received placebo matched to suzetrigine (SUZ) and hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days.

Drug: Placebo (matched to SUZ); Drug: Placebo (matched to HB/APAP)

Hydrocodone bitartrate/acetaminophen (HB/APAP)

ACTIVE COMPARATOR

Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 2 days.

Drug: HB/APAP; Drug: Placebo (matched to SUZ)

Suzetrigine (SUZ)

EXPERIMENTAL

Participants received SUZ \[100 mg as first dose, followed by 50 mg every 12 hours (q12h)\] for 2 days.

Drug: SUZ; Drug: Placebo (matched to HB/APAP)

Interventions

SUZ DRUG

Tablets for oral administration.

Also known as: VX-548

Suzetrigine (SUZ)

HB/APAP DRUG

Capsules for oral administration.

Hydrocodone bitartrate/acetaminophen (HB/APAP)

Placebo (matched to SUZ) DRUG

Placebo matched to SUZ for oral administration.

Hydrocodone bitartrate/acetaminophen (HB/APAP); Placebo

Placebo (matched to HB/APAP) DRUG

Placebo matched to HB/APAP for oral administration.

Placebo; 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:

• Before Surgery
• Participants scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic block)
• After Surgery
• Participant is lucid and able to follow commands
• All analgesic guidelines were followed during and after the bunionectomy

You may not qualify if:

• Before Surgery
• Prior history of bunionectomy or or other foot surgery on the index foot; or bunionectomy on the opposite foot
• History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s)
• Any prior surgery within 1 month before the first study drug dose
• After Surgery
• Participant had a type 3 deformity requiring a base wedge osteotomy, concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy
• Participant had a medical complication during the bunionectomy that, in the opinion of the investigator, should preclude randomization

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (21)

Shoals Medical Trials Inc.

Sheffield, Alabama, 35660, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Trovare Clinical Research

Bakersfield, California, 93301, United States

Location

Pacific Research Network Inc

San Diego, California, 92103, United States

Location

New Hope Research Development

Tarzana, California, 91356, United States

Location

New Hope Research Development

West Covina, California, 91790, United States

Location

Clinical Pharmacology of Miami

Hialeah, Florida, 33014, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Kansas Spine and Specialty Hospital

Wichita, Kansas, 67226, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, 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

HD Research LLC | Houston Heights Hospital

Houston, Texas, 77008, United States

Location

Futuro Clinical Trials

McAllen, Texas, 78501, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

Location

Houston Physicians Hospital

Webster, Texas, 77598, 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

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: October 3, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: August 1, 2025
• Results First Posted: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)