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NCT05661734

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

Completed Phase 3 Results posted Last updated 1 July 2025
What this trial tests

Phase 3 trial testing Suzetrigine in Pain in 258 participants. Completed in 12 December 2023.

Timeline
9 January 2023
Primary endpoint
12 December 2023
12 December 2023

Quick facts

Lead sponsorVertex Pharmaceuticals Incorporated
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment258
Start date9 January 2023
Primary completion12 December 2023
Estimated completion12 December 2023
Sites14 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Vertex Pharmaceuticals Incorporated — full company profile →

Who can join

Adults 18 to 80, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Primary · Day 1 up to Day 30
Participants with TEAEs
GroupValue95% CI
Suzetrigine (SUZ)94
Participants with SAEs
GroupValue95% CI
Suzetrigine (SUZ)2
Percentage of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) Scale Secondary · Day 14 or at Pain Resolution, whichever occurs first

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.

GroupValue95% CI
Suzetrigine (SUZ)83.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 up to Day 30. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Suzetrigine (SUZ)
Serious: 2/256 (1%)
Deaths: 0/256

Serious adverse events (2 terms)

ReactionSystemSuzetrigine (SUZ)
CellulitisInfections and infestations
Suicidal ideationPsychiatric disorders
Other adverse events (1 terms — click to expand)

ReactionSystemSuzetrigine (SUZ)
HeadacheNervous system disorders

Most-reported serious reactions: Cellulitis, Suicidal ideation.

Data from ClinicalTrials.gov NCT05661734 adverse events section.

Sponsor's own description

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

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Suzetrigine, a Non-Opioid Na<sub>V</sub>1.8 Inhibitor With Broad Applicability for Moderate-to-Severe Acute Pain: A Phase 3 Single-Arm Study for Surgical or Non-Surgical Acute Pain.
    McCoun J, Winkle P, Solanki D, Urban J, et al · · 2025 · cited 17× · PMID 40165940 · DOI 10.2147/jpr.s509144
  2. Suzetrigine for moderate to severe acute pain.
    Cho EB, Jiang C, Wang Z, Yu Y, et al · · 2025 · cited 4× · PMID 40133193 · DOI 10.1016/j.tips.2025.02.008
  3. Suzetrigine, a Non-Opioid Small-Molecule Analgesic: Mechanism of Action, Clinical, and Translational Science.
    Rajasingham R, Qi Y. · · 2025 · cited 3× · PMID 41251403 · DOI 10.1111/cts.70414
  4. Suzetrigine, a Na<sub>V</sub>1.8 Inhibitor as a Novel Approach for Pain Therapy-A Medicinal and Chemical Drug Profile.
    Medhat RM, Kotb OA, Baecker D. · · 2026 · cited 1× · PMID 41599406 · DOI 10.3390/molecules31020358
  5. Transforming Pain Management: Suzetrigine, a Novel Non-Opioid Analgesic.
    AlDoughaim M, AlSuhebany N, AlZahrani M, AlDairem A, et al · · 2025 · cited 1× · PMID 41027858 · DOI 10.4062/biomolther.2025.046
  6. Suzetrigine: What Should Plastic Surgeons Know?
    Wiegmann AL, Markewych AN, Cook JQ, Jejurikar S, et al · · 2026 · PMID 41858707 · DOI 10.1097/gox.0000000000007431
  7. Selective Nav1.8 inhibition by suzetrigine, a novel nonopioid analgesic for acute pain management: A systematic review and metanalysis.
    Bansal S, Gupta SK, Dutta S, Shah RB, et al · · 2026 · PMID 41710612 · DOI 10.4103/sja.sja_602_25

Verify or expand the search:

Other trials of Suzetrigine

Trials testing the same drug.

Other recruiting trials for Pain

Currently open trials in the same condition.

Other Vertex Pharmaceuticals Incorporated trials

Trials by the same sponsor.

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Data sources for this page

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