PainPhase 3NCT05661734

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

A Phase 3 study testing Suzetrigine in people with Pain, run by Vertex Pharmaceuticals Incorporated at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Pain
What is being tested?: Suzetrigine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 258 participants
Where: 14 sitesUnited States
Study dates: 9 Jan 2023to 12 Dec 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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
Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Anaheim Clinical Trials
Anaheim, California, 92801
Atlanta Center for Medical Research | Atlanta, GA
Atlanta, Georgia, 30331
Trovare Clinical Research | Bakersfield, CA
Bakersfield, California, 93301
HD Research LLC | First Surgical Hospital
Bellaire, Texas, 77401
HD Research LLC | Legent Orthopedic Hospital
Carrollton, Texas, 75006
Renovatio Clinical
Houston, Texas, 77380
Center for Orthopaedic Reconstruction and Excellence
Jenks, Oklahoma, 74037
Futuro Clinical Trials
McAllen, Texas, 78501
Mart Medical Research Group LLC
Miami, Florida, 33166
OrthoNebraska Hospital
Omaha, Nebraska, 68144
Wasatch Clinical Research
Salt Lake City, Utah, 84107
South Texas Spine & Surgical Hospital
San Antonio, Texas, 78258
Mart Medical Research Group LLC
South Miami, Florida, 33143
Cypress Surgery Center
Wichita, Kansas, 67226

Other trials in United States

About this study

Official title: A Phase 3, Single-arm Study Evaluating the Safety and Effectiveness of VX-548 for Acute Pain

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

Conditions: Pain
Being tested: Suzetrigine
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SuzetrigineDrug
Also called VX-548, SUZ
Tablets for oral administration.

Study groups in NCT05661734
Study group	Role	What they receive
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. Receives: Drug: Suzetrigine

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: 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
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 5-point Likert scale as: (poor, fair, good, very good or excellent). Percentage of participants who reported good, very good or excellent on the PGA scale was reported.
Measured: Day 14 or at Pain Resolution, whichever occurs first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jan 202312 Dec 2023

First posted22 Dec 2022
Study start9 Jan 2023
Primary completion12 Dec 2023
Study completion12 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 258 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05661734
Sponsor's protocol ID: VX22-548-107
Status last verified: Jun 2025
First submitted: 14 Dec 2022
Last updated: 1 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: 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

Publications

Yuan S, Ji H, Lu Y, Zhang Z, Tang H. The Clinical Application of Suzetrigine. J Pain Palliat Care Pharmacother. 2026 Jun;40(2):311-320. doi: 10.1080/15360288.2026.2624502. Epub 2026 Feb 14.
PubMed 41689837
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.
PubMed 40165940

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Single-arm Study Evaluating the Safety and Effectiveness of VX-548 for Acute Pain
ClinicalTrials.gov ID: NCT05661734
Acronym / sponsor ID: VX22-548-107
Conditions: Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 258 participants (actual)
Lead sponsor: Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
Study start: 9 Jan 2023 (actual)
Primary completion: 12 Dec 2023 (actual)
Study completion: 12 Dec 2023 (actual)
First posted: 22 Dec 2022 (actual)
Results: Posted 1 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Suzetrigine (SUZ)	Experimental	Drug: SuzetrigineParticipants 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

Surgical participants:
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
Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SuzetrigineAlso: VX-548, SUZTablets for oral administration.	Drug	Suzetrigine (SUZ)

Primary outcome

Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to Day 30

1 secondary outcome

Percentage of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) Scale
Time frame: Day 14 or at Pain Resolution, whichever occurs first

Results and safety

Results posted to the registry on 1 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Suzetrigine (SUZ)	258	240

Primary outcome: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame: Day 1 up to Day 30. Count of participants. Unit: Participants

Measure	Suzetrigine (SUZ) n = 256
Participants with TEAEs	94
Participants with SAEs	2

Population analysed: Safety Set included all participants who received at least 1 dose of study drug.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day 1 up to Day 30. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Suzetrigine (SUZ)	2 of 256 (0.8%)	18 of 256 (7%)	0 of 256

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41689837Yuan S, Ji H, Lu Y, Zhang Z, Tang H. The Clinical Application of Suzetrigine. J Pain Palliat Care Pharmacother. 2026 Jun;40(2):311-320. doi: 10.1080/15360288.2026.2624502. Epub 2026 Feb 14.
Derived from this study: PubMed 40165940McCoun 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.
Individual participant dataSharing planned: No. 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Suzetrigine in people with Pain, run by Vertex Pharmaceuticals Incorporated at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Day 1 up to Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05661734, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.