Evaluation of Efficacy and Safety of Suzetrigine for Acute Pain After an Abdominoplasty

A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Suzetrigine for Acute Pain After an Abdominoplasty

The purpose of this study was to evaluate the efficacy and safety of Suzetrigine (SUZ) in treating acute pain after an abdominoplasty.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Placebo (matched to HB/APAP); Drug: HB/APAP; Drug: Placebo (matched to SUZ); Drug: Suzetrigine (SUZ)

• Study Type: Interventional
• Enrollment (Actual): 1118
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Sheffield, Alabama, United States, 35660
      • Shoals Medical Trials Inc.
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Arizona Research Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group
  • California
    • Canoga Park, California, United States, 91304
      • Alliance Research Institute, LLC
    • Tarzana, California, United States, 91356
      • New Hope Research Development
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research | Atlanta, GA
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Kansas Spine and Specialty Hospital
  • Texas
    • Bellaire, Texas, United States, 77401
      • HD Research LLC | First Surgical Hospital
    • Houston, Texas, United States, 77008
      • HD Research LLC | Houston Heights Hospital
    • San Antonio, Texas, United States, 78240
      • Endeavor Clinical Trials
    • San Antonio, Texas, United States, 78258
      • South Texas Spine & Surgical Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • JBR 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:

• Before Surgery

  • Participant scheduled to undergo a standard ("full") abdominoplasty procedure

• After Surgery

  • Participant is lucid and able to follow commands and able to swallow oral medications
  • All analgesic guidelines were followed during and after the abdominoplasty
  • Abdominoplasty procedure duration less than or equal to (≤3) hours

Key Exclusion Criteria:

• Before Surgery

  • Prior history of abdominoplasty
  • History of Intra-abdominal and/or pelvic surgery that resulted into complications
  • 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 non standard abdominoplasty, collateral procedures during the abdominoplasty or any surgical complications during the abdominoplasty
  • Participant had a medical complication during the abdominoplasty that, in the opinion of the investigator, should preclude randomization

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received placebo matched to Suzetrigine (SUZ) and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 48 hours.	Drug: Placebo (matched to HB/APAP); Placebo matched to HB/APAP for oral administration.; Drug: Placebo (matched to SUZ); Placebo matched to SUZ for oral administration.
Active Comparator: Hydrocodone bitartrate/acetaminophen (HB/APAP); Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 48 hours.	Drug: HB/APAP; Capsules for oral administration.; Drug: Placebo (matched to SUZ); Placebo matched to SUZ for oral administration.
Experimental: Suzetrigine (SUZ); Participants received SUZ [100 mg as first dose, followed by 50 mg every 12 hours (q12h)] for 48 hours.	Drug: Placebo (matched to HB/APAP); Placebo matched to HB/APAP for oral administration.; Drug: Suzetrigine (SUZ); Tablets for oral administration.; Other Names: VX-548

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 by 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 by subtracting the baseline pain intensity score from the pain intensity score at each post dose 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
Time to Greater Than or Equal to (≥) 2-point Reduction in NPRS, SUZ Compared to Placebo	Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The time to ≥2-point reduction in NPRS from baseline was the time elapsed from the first dose of study drug until the first time the participant had at least a 2-point reduction in NPRS scores from baseline. Participants who did not reach at least a 2-point reduction in NPRS from baseline by 48 hours were censored at 48 hours.	From Baseline Up to 48 Hours After First Dose of Study Drug
Time to ≥1-point Reduction in NPRS, SUZ Compared to Placebo	Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The time to ≥1-point reduction in NPRS from baseline was the time elapsed from the first dose of study drug until the first time the participant had at least a 1-point reduction in NPRS scores from baseline. Participants who did not reach at least a 1-point reduction in NPRS from baseline by 48 hours were censored at 48 hours.	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	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 4-point Likert scale as: (poor, fair, good, or excellent). Percentage of participants who reported good or excellent on the PGA scale were reported. Participants who discontinued study drug or had missing PGA at 48 hours were considered to not have reported good or excellent on the PGA.	At 48 hours
Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP	The incidence with the events of vomiting or nausea during the specified time frame was reported.	From Baseline Up to Day 19
Time-weighted SPID as Recorded on the NPRS From 0 to 24 Hours (SPID24), 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 (PID) was calculated by subtracting the baseline pain intensity score from the pain intensity score at each post dose time point (NPRS range: 0 = no pain to 10 = worst possible pain). Time-weighted SPID was calculated as the sum of the PIDs at each post-dose time point multiplied by the time interval (in hours) between each time point. SPID 24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).	0 to 24 Hours After First Dose of Study Drug
Time to First Use of Rescue Medication, SUZ Compared to Placebo	Time to first use of rescue medication is the time from the first dose of study drug until the first use of rescue medication. Participants who did not take any rescue medication within 48 hours were censored at 48 hours.	0 to 48 Hours After First Dose of Study Drug
Percentage of Participants Using Rescue Medication From 0 to 48 Hours, SUZ Compared to Placebo		0 to 48 Hours After First Dose of Study Drug
Total Rescue Medication Usage, SUZ Compared to Placebo		0 to 48 Hours After First Dose of Study Drug
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 19

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): August 25, 2023
• Study Completion (Actual): September 11, 2023

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Acetaminophen
• Other Study ID Numbers: VX22-548-105

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