What are the primary evidence and recommendations surrounding suzetrigine (Journavx)?

Comment by InpharmD Researcher

See Tables 1-3 for available clinical trial evidence for suzetrigine that has been published to date. Two phase 3 trials in moderate-to-severe acute pain (NAVIGATE 1 and NAVIGATE 2) found suzetrigine to reduce moderate-to-severe acute pain over 48 hours after abdominoplasty or bunionectomy, with pain reduction similar to hydrocodone/acetaminophen. While results from the phase 2 trial evaluating suzetrigine in diabetic peripheral neuropathy have been published on ClinicalTrials.gov, results have not been posted or published for the phase 3 trial; the estimated study completion date is May 31, 2027. A recent Institute for Clinical and Economic Review (ICER) report found a slight cost benefit to using suzetrigine compared to hydrocodone/acetaminophen therapy alone. Additionally, a recent meta-analysis supports a significant analgesic benefit in patients undergoing abdominoplasty who receive suzetrigine, suggesting that suzetrigine might be a promising nonopioid alternative for effective perioperative pain relief without the adverse effects associated with opioid-based treatments.

Background

The Institute for Clinical and Economic Review (ICER) conducted a review of the value and effectiveness of suzetrigine compared to opioid analgesics. Results were based on the use of suzetrigine or hydrocodone 5 mg/acetaminophen 325 mg for one week postoperatively and the assumption that a one-week course of hydrocodone/acetaminophen would result in an excess of 2 in 10,000 cases of opioid use disorder in the subsequent three years. The report found a slight cost benefit to using suzetrigine compared to hydrocodone/acetaminophen therapy alone. Comparisons are not available to hydrocodone/acetaminophen or suzetrigine therapy with rescue medications or suzetrigine compared to non-opioid therapies alone. [1]

A 2025 systematic review and meta-analysis synthesized data from four randomized controlled trials evaluating suzetrigine for perioperative pain management. This analysis involved 2,768 adult patients undergoing various surgical procedures, with 1,179 patients receiving suzetrigine, an inhibitor of the Nav 1.8 sodium channel, recently approved by the US FDA. The trials compared suzetrigine against both placebo and a standard analgesic regimen comprising hydrocodone with paracetamol. The primary outcome measured was the Summed Pain Intensity Difference over a 48-hour period (SPID-48). This outcome was gauged using a numeric rating scale to assess pain relief over time, comparing initial pain scores to subsequent ratings. The meta-analysis showed that suzetrigine was significantly more effective in reducing pain compared with placebo, evidenced by a mean difference (MD) of 38.64 and a 95% confidence interval (CI) ranging from 26.96 to 47.32. Although the efficacy of suzetrigine did not differ statistically from hydrocodone with paracetamol (MD of 5.27; 95% CI -15.03, 25.57), its safety profile was favorable, with reduced general adverse events (risk ratio 0.83; 95% CI: 0.76, 0.90) and no significant increase in severe adverse events. Notably, significant analgesic benefits were observed in patients undergoing abdominoplasty, suggesting that suzetrigine might be a promising nonopioid alternative for effective perioperative pain relief without the adverse effects associated with opioid-based treatments. However, the authors noted limitations, including potential bias due to industry sponsorship, and highlighted the necessity for further research to confirm these findings across broader populations. [2]

References:

[1] Rind DM, McQueen B, Nikitin D, Lee W, DiStefano MJ, Raymond F, Zemplenyi A, Ollendorf D. Suzetrigine for Acute Pain; Evidence Report. Institute for Clinical and Economic Review, February 5, 2025. https://icer.org/assessment/acute-pain-2025/
[2] Amaral S, Marques N, Tapioca V, Pereira E, Americo A, Gadsden J. Suzetrigine for acute postoperative pain: a systematic review and meta-analysis of current evidence. Br J Anaesth. Published online July 10, 2025. doi:10.1016/j.bja.2025.06.014
Literature Review

A search of the published medical literature revealed 3 studies investigating the researchable question:

What is the safety and efficacy of Journavx (suzetrigine) for pain?

Level of evidence

B - One high-quality study or multiple studies with limitations  Read more→


Please see Tables 1-3 for your response.

 

Suzetrigine, a Non-Opioid NaV1.8 Inhibitor for Treatment of Moderate-to-Severe Acute Pain: Two Phase 3 Randomized Clinical Trials

Design

Two phase 3, randomized, double-blind, placebo- and active-controlled trials

NAVIGATE 2 (post abdominoplasty; N= 1,118)

NAVIGATE 1 (post bunionectomy; N= 1,073)

Objective

To evaluate the efficacy and safety of suzetrigine in participants with moderate-to-severe acute pain after abdominoplasty or bunionectomy

Study Groups

Abdominoplasty (N= 1,118)

Suzetrigine (n= 447)

Hydrocodone bitartrate/acetaminophen (HB/APAP) (n= 448)

Placebo (n= 223)

Bunionectomy (N= 1,073)

Suzetrigine (n= 426)

Hydrocodone bitartrate/acetaminophen (HB/APAP) (n= 431)

Placebo (n= 216)

Inclusion Criteria

Age 18 to 80 years old, requested study drug for pain relief following abdominoplasty procedure under general anesthesia or a primary unilateral bunionectomy under regional anesthesia, pain rated as moderate or severe on verbal categorical rating scale (VRS) and ≥ 4 on numeric pain rating scale (NPRS)

Exclusion Criteria

Sensory abnormality or physical condition deemed serious enough to interfere with assessing postoperative pain, long-term opioid or non-steroidal anti-inflammatory drug (NSAID) use

Methods

In both trials, patients were randomized 2:2:1 to receive either suzetrigine, HB/APAP, or placebo during a 48-hour treatment period. Suzetrigine was administered as oral tablets, with loading dose of 100 mg followed by 50 mg every 12 hours. HB/APAP (active control) was given orally as 5 mg/325 mg capsules every 6 hours.  

Duration

Trial: 2022 to 2023

Intervention: 48 hours

Outcome Measures

Primary: Sum of the pain intensity difference for suzetrigine compared to placebo per NPRS from 0 to 48 hours (SPID48) after the first dose of study drug

Secondary: SPID48 for suzetrigine compared to HB/APAP; time to ≥2-point reduction in NPRS from baseline for suzetrigine compared to placebo

Baseline Characteristics

  

Abdominoplasty (N= 1,118)

Bunionectomy (N= 1,073)

  

Age, years

 42 48  

Female

98% 85%  

Race

White

Black

 

70%

27%

 

71%

24%

  

BMI, kg/m2

 29 28  

NPRS

< 8

≥ 8

7.4

51%

49%

6.8

64%

36%

  

VRS

Moderate

Severe

 

59%

41%

 

67%

33%

  

Results

Abdominoplasty

 

Suzetrigine (n= 447)

 Placebo (n= 223) or HB/APAP (n= 431) Mean difference (95% CI); p-Value

SPID48

 118.4 ± 4.3

70.1 ± 6.1 - Placebo

111.8 ± 4.3 - HB/APAP

48.4 (33.6 to 63.1); < 0.0001

6.6 (-5.4 to 18.7); 0.2781

Time to ≥ 2-point reduction in NPRS from baseline, min

 119

480

--; < 0.0001

Bunionectomy 

 

 Suzetrigine (n= 426) Placebo (n= 216) Mean difference (95% CI); p-Value

SPID48

 99.9 ± 4.5

70.6 ± 6.3 - Placebo

120.1 ± 4.5 - HB/APA

29.3 (14.0 to 44.6); 0.0002

-20.2 (-32.7 to -7.7); 0.0016

Time to ≥ 2-point reduction in NPRS from baseline, min

 240 480  --; 0.0016 

Results above presented for pre-specified analysis with rescue imputation. 

Adverse Events

Common Adverse Events (≥ 4%): nausea, constipation, headache, dizziness, hypotension, vomiting

Any adverse event:

Abdominoplasty trial: 50.0% suzetrigine, 60.7% HB/APA, 56.3% placebo

Bunionectomy trial: 31.0% suzetrigine, 41.8% HB/APA, 35.2% placebo

Serious Adverse Events: 

Abdominoplasty trial: 2.5% suzetrigine, 1.6% HB/APA, 2.3% placebo (none considered related or possibly related to suzetrigine)

Bunionectomy trial: None reported

Percentage that Discontinued due to Adverse Events: (if not listed in study, use N/A or “Not disclosed”)

Abdominoplasty trial: 1.1% suzetrigine, 1.1% HB/APAP, 0.5% placebo

Bunionectomy trial: None reported

Study Author Conclusions

Suzetrigine reduced moderate-to-severe acute pain over 48 hours after abdominoplasty or bunionectomy, with pain reduction similar to HB/APAP. Adverse events were mild to moderate.

InpharmD Researcher Critique

The study's strengths include its large sample size and rigorous design. Limitations include the predominantly female participant pool and the use of rescue medication, which may affect the interpretation of efficacy results. Further studies could explore suzetrigine's role in multimodal pain management strategies



References:

Bertoch T, D'Aunno D, McCoun J, et al. Suzetrigine, a Non-Opioid NaV1.8 Inhibitor for Treatment of Moderate-to-Severe Acute Pain: Two Phase 3 Randomized Clinical Trials. Anesthesiology. Published online March 21, 2025. doi:10.1097/ALN.0000000000005460

 

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
Design

Phase 3, single-arm study

N= 256
Objective

To evaluate the safety and effectiveness of suzetrigine for the treatment of moderate-to-severe acute surgical and non-surgical pain conditions
Study Groups

All participants (n= 256)
Inclusion Criteria

Adults, 18 to 80 years of age, with moderate or severe acute pain on the verbal categorical rating scale and ≥4 on the numeric pain rating scale following surgical procedures or after presenting to a medical facility with non-surgical pain of new origin
Exclusion Criteria History of previous surgery due to same condition or in same region of body resulting in perioperative complications, serious illness that could interfere with study
Methods

Participants received suzetrigine (100 mg first dose, then 50 mg every 12 hours) for 14 days or until pain resolution. Concomitant acetaminophen (650 mg) and ibuprofen (400 mg) every 6 hours were allowed as rescue medication
Duration

January 2023 to December 2023
Outcome Measures

Primary: Safety and tolerability based on treatment-emergent adverse events (AEs)

Secondary: Participant perception of suzetrigine’s effectiveness in treating acute pain using a patient global assessment (PGA)
Baseline Characteristics Characteristic

Suzetrigine (n= 256)
Age, years

43.9 ± 14.1
Female

173 (67.6%)

Race

White

Black/African American

 

214 (83.6%)

34 (13.3%)
BMI, kg/m2

29.29 ± 4.91
Numeric pain rating scale (NPRS) score

6.7 ± 1.7

Surgical status

Surgical

Non-surgical

 

222 (86.7%)

34 (13.3%)
Results Outcome Suzetrigine (n= 256)
Participants with any AEs

94 (36.7%)

Participants with AEs by maximum severity

Mild

Moderate

Severe

71 (27.7%)

21 (8.2%)

2 (0.8%)

Participants with serious AEs

 2 (0.8%)

Participants with AEs leading to treatment discontinuation

 5 (2.0%)

AEs occurring in ≥2% of participants

Headache

Constipation

Nausea

Fall

Rash

 

18 (7.0%)

9 (3.5%)

8 (3.1%)

6 (2.3%)

5 (2.0%)

Participants reporting good, very good, or excellent on PGA

Surgical patients

Non-surgical patients 

213 of 256 (83.2%)

182 of 222 (82.0%)

31 of 34 (91.2%)
Adverse Events Most adverse events were mild or moderate. Common adverse events included headache (7.0%), constipation (3.5%), nausea (3.1%), fall (2.3%), and rash (2.0%). Serious adverse events included cellulitis and suicidal ideation, both considered not related to suzetrigine
Study Author Conclusions Suzetrigine provides a safe and effective non-opioid, non-addictive treatment with broad applicability for moderate-to-severe acute pain
Critique The study's single-arm design limits the ability to compare suzetrigine's effectiveness against placebo or active controls. However, the results are consistent with previous trials, supporting suzetrigine's effectiveness across various acute pain conditions. Further studies could explore its role in multimodal therapy. A very small subgroup of patients were treated for non-surgical pain. 

 

References:

McCoun J, Winkle P, Solanki D, et al. 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;18:1569-1576. Published 2025 Mar 25. doi:10.2147/JPR.S509144

Clinical Trial Data for Suzetrigine

Trial Description

 Study Design Methods Outcomes Results

Vertex. Vertex Announces Results From Phase 2 Study of Suzetrigine for the Treatment of Painful Lumbosacral Radiculopathy. Press Release Vertex. Published December 19, 2024. Accessed July 21, 2025.

Objective: To determine the effectiveness and safety of suzetrigine following painful lumbosacral radiculopathy (LSR)

Comparator agent: Placebo

Phase 2, randomized, double blind, placebo-controlled study

Study Population (N= 218)

Suzetrigine (n = 102) Placebo (n= 100)

Inclusion criteria:

Adults 18-79 years old with painful lumbosacral radiculopathy (LSR) lasting >3 months; moderate-to-severe pain (Numeric Pain Rating Scale [NPRS] 4-10)

 

Exclusion criteria:

Patients with painful neuropathy other than LSR, history of prior lumbar spine surgery

 

Intervention:

Patients completed a 7-day run-in period, were randomized to receive suzetrigine 69 mg daily or placebo (1:1) and treated for 12 weeks and finally were followed-up for 14 days. Pain medications, except stable over-the-counter doses of ibuprofen (up to 1600 mg/24-hour) or naproxen (up to 440 mg/24-hour), were stopped at least 14 days prior to first dose. Acetaminophen (up to 500 mg every 4 to 6 hours, as needed) was allowed during the run-in period and throughout the study

Primary outcome:

Within-group change from baseline in the weekly average of daily leg pain intensity on NPRS at week 12

 

Secondary/safety outcomes:

Within-group change from baseline in the weekly average of the daily sleep interference scale (DSIS) at week 12; safety and tolerability

Primary outcome:

Mean NPRS

  • Suzetrigine: 6.33 ± 1.22
  • Placebo: 6.05 ± 1.07

Least squares mean change in NPRS at week 12

  • Suzetrigine -2.02 (95% CI -2.40 to -1.64; p< 0.0001) vs. placebo: -1.98 (95% CI -2.36 to -1.60; p< 0.0001)

 

Secondary outcomes:

Approximately 40% of clinical trial sites had a lower placebo response. Analyses of the primary and other endpoints at these sites showed suzetrigine arm within-group reduction in pain was consistent with the overall study and had greater separation from the placebo arm.

 

Safety outcomes:

Any AEs:

  • 9% suzetrigine vs. 32.4% placebo

Serious AEs:

  • 9% suzetrigine vs 1.9% placebo

AEs leading to treatment discontinuation:

0 suzetrigine vs 0.9% placebo

Jones J, Correll DJ, Lechner SM, et al. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. N Engl J Med. 2023;389(5):393-405. doi:10.1056/NEJMoa2209870

Objective: To evaluate the efficacy and safety of VX-548, an oral and highly selective NaV1.8 inhibitor, for the treatment of acute pain

Comparator agent: Hydrocodone-acetaminophen and placebo

Two phase 2, randomized, double-blind, placebo-controlled trials (NCT05558410 and NCT05553366)

Study Population (N= 577)

Abdominoplasty trial group (n= 303)

Bunionectomy trial group (n= 274)

Inclusion criteria:

Participants scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia OR abdominoplasty without collateral procedures.

 

Exclusion criteria:

Patients with a history of cardiac dysrhythmia.

 

Intervention:

In the abdominoplasty trial, participants were assigned for 48 hours to receive in a 1:1:1:1 ratio:

  • High-dose suzetrigine (loading dose [LD] 100 mg, then 50 mg q12h)
  • Middle-dose suzetrigine (LD 60 mg, then 30 mg q12h)
  • Hydrocodone-acetaminophen (5/325 mg q6h)
  • Placebo

Those in the bunionectomy trial participants were randomly assigned in a 2:2:1:2:2 ratio to receive:

  • High-dose suzetrigine
  • Middle-dose suzetrigine
  • Low-dose suzetrigine (loading 20 mg, then 10 mg q12h)
  • Hydrocodone-acetaminophen
  • Placebo

Primary outcome:

Least-squares mean difference (LSMD) in time-weighted sum of the pain-intensity difference (SPID48)

 

Secondary/safety outcomes:

Time-weighted SPID over 24 hours (SPID24); responder rates at 48 hours

Primary outcome:

High-dose suzetrigine significantly reduced pain compared to placebo, with least-squares mean differences in SPID48 of:

  • 8 (95% confidence interval [CI] 9.2 to 66.4) for abdominoplasty
  • 8 (95% CI 4.6 to 69.0) for bunionectomy.
  • Lower doses of suzetrigine produced outcomes similar to placebo.

 

Secondary outcomes:

The high-dose suzetrigine arm also yielded higher percentages of participants achieving ≥30%, ≥50%, and ≥70% reductions in NPRS scores at 48 hours compared to placebo.

 

Safety outcomes:

  • AEs were mild to moderate and occurred more frequently with high-dose suzetrigine than placebo (headache, 14% vs. 6%; constipation 9% vs. 5%).
No serious safety concerns (incision-site cellulitis, sepsis, laryngeal stenosis, pulmonary embolism) were attributed to the intervention and all events were resolved.

ClinicalTrials.gov. Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN). Updated July 1, 2025. Accessed July 21, 2025. NCT05660538

Objective: To evaluate the efficacy and safety of VX-548 doses in treating painful DPN

Comparator agent: Pregabalin and placebo

Phase 2, randomized, double-blind, active-controlled, dose-ranging, parallel-design Study

Study Population (N= 173)

Pregabalin (n= 49)

Suzetrigine low-dose (n= 24)

Suzetrigine mid-dose (n= 50)

Suzetrigine high-dose: (n= 50)

Inclusion criteria: 

Type 1 or 2 diabetes mellitus diagnosis; bilateral pain in lower extremities due to DPN for ≥1 year; HbA1c ≤9%

 

Exclusion criteria: 

Painful neuropathy other than DPN; cardiac dysrhythmia requiring anti-arrhythmia treatment; clinical atherosclerotic event within the past 12 months.

 

Intervention: 

Patients were randomized to receive pregabalin 100 mg TID for 12 weeks, suzetrigine 23 mg QD for 12 weeks (low-dose), suzetrigine 46 mg QD for 12 weeks (mid-dose), or suzetrigine 69 mg QD for 12 weeks (high-dose).

Primary outcome:

Change in weekly average daily pain intensity on a numeric rating scale

 

Secondary/safety outcomes:

Change in weekly average sleep, weekly average daily pain intensity that was ≥30-70%, patient global impression of change (PGIC) assessment, and safety and tolerability

Primary outcome:

Least squares mean (LSM) change in weekly average daily pain intensity from baseline (95% confidence interval [CI])

  • Pregabalin: -2.09 (-2.65 to -1.52
  • Suzetrigine (low-dose): -2.18 (-2.94 to -1.41)
  • Suzetrigine (mid-dose): -2.11 (-2.67 to -1.55)
  • Suzetrigine (high-dose): -2.26 (-2.82 to -1.70)

 

Secondary outcomes:

LSM change from baseline in weekly average daily sleep interference scale (DSIS) score (95% CI):

  • Pregabalin: -2.42 (-3.02 to -1.83)
  • Suzetrigine (low-dose): -2.20 (-3.00 to -1.41)
  • Suzetrigine (mid-dose): -2.44 (-3.01 to -1.87)
  • Suzetrigine (high-dose): -2.15 (-2.74 to -1.55)

 

Percentage with ≥30%,  ≥50%, and ≥70% reduction from baseline in weekly average daily pain intensity:

  • Pregabalin: 44.9%, 22.4%, 10.2%
  • Suzetrigine (low-dose): 70.8%, 41.7%, 8.3%
  • Suzetrigine (mid-dose): 46.0%, 32.0%, 22.0%
  • Suzetrigine (high-dose): 48.0%, 34.0%, 22.0%

 

Percentage categorized as “much improved” or “very much improved” on PGIC assessment:

  • Pregabalin: 46.9%
  • Suzetrigine (low-dose): 50.0%
  • Suzetrigine (mid-dose): 52.0%
  • Suzetrigine (high-dose): 50.0%

 

Safety outcomes:
Treatment-emergent adverse events (TEAEs):

  • Pregabalin: 20
  • Suzetrigine (low-dose): 14
  • Suzetrigine (mid-dose): 21
  • Suzetrigine (high-dose): 31

 

Serious adverse events (SAEs):

  • Pregabalin: 1
  • Suzetrigine (low-dose): 0
  • Suzetrigine (mid-dose): 2

Suzetrigine (high-dose): 1

ClinicalTrials.gov. Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy. Updated June 26, 2025. Accessed July 21, 2025. NCT06628908

Objective: To evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with DPN

Comparator agent: Pregabalin and placebo

Phase 3, randomized, double-blind, placebo- and active-controlled Study

Study Population (N= 1100)

VX-548

Pregabalin

Placebo

Inclusion criteria:

Body weight ≥45 kg; body mass index (BMI) ≥18.0 to <40.0 kg/m^2; diagnosis of DM type 1 or type 2 by HbA1c ≤9% and the presence of bilateral pain in lower extremities due to DPN; weekly average of daily Numeric Pain Rating Scale (NPRS) score ≥4 and ≤9 with limited variation in the 7-day baseline period

 

Exclusion criteria:

>3 missing daily NPRS scores during the 7-day baseline period; participation in a previous study in which the participant received VX-548; any sensory abnormality (excluding DPN) as pre-specified in the protocol

 

Intervention:

Participants were randomized to VX-548, a matched placebo for VX-548, pregabalin, or a matched placebo for pregabalin. All interventions were administered in tablet or capsule form according to their respective treatment groups.

Primary outcome:

Change from baseline in the weekly average of daily pain intensity on the numeric pain rating scale (NPRS) at week 12 compared to placebo

 

Secondary outcome:

Change from baseline in the weekly average of daily pain intensity on the NPRS at week 12 compared to pregabalin; change from baseline in 36-item short-form health status (SF-36v2) physical component summary (PCS) score at week 12 compared to placebo

Outcomes:

Results have not been posted or published. The estimated study completion date is May 31, 2027.

ClinicalTrials.gov. A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain. Updated July 1, 2025. Accessed July 21, 2025. NCT05661734

Objective: To evaluate the safety and effectiveness of suzetrigine (VX-548) for acute pain

Comparator agent: No comparator agent

Phase 3, single-arm study

Study Population (N= 258)

VX-548 (n= 258)

Inclusion criteria:

Patients aged 18 to 80 years with BMI ≥18 and <40 kg/m2; non-surgical patients with new moderate-to-severe pain and surgical patients reporting pain at the surgical site that is moderate or severe.

 

Exclusion criteria:

History of previous surgery due to same condition; prior surgical procedure resulting in perioperative complications.

 

Intervention:

Patients received suzetrigine tablets PO Q12H up to 14 days.

Primary outcome:

Safety and tolerability as assessed by number of participants with AEs and serious adverse events (SAEs)

 

Secondary/safety outcomes:

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

Outcomes:

TEAEs: 94

SAEs: 2

Proportion of participants Reporting Good, Very Good, or Excellent on PGA: 83.2%
References:

[1] Vertex. Suzetrigine (VX-548) Phase 2 Results In Painful Lumbosacral Radiculopathy. December 19, 2024. Accessed July 21, 2025. https://investors.vrtx.com/static-files/0149bf23-3d32-41b5-8ca8-ec22c65f968d
[2] Jones J, Correll DJ, Lechner SM, et al. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. N Engl J Med. 2023;389(5):393-405. doi:10.1056/NEJMoa2209870
[3] ClinicalTrials.gov. Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN). Updated July 1, 2025. Accessed July 2, 2025 https://clinicaltrials.gov/study/NCT05660538
[4] ClinicalTrials.gov. Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy. Updated June 26, 2025. Accessed July 2, 2025. https://clinicaltrials.gov/study/NCT06628908
[5] ClinicalTrials.gov. A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain. Updated July 1, 2025. Accessed July 2, 2025. https://clinicaltrials.gov/study/NCT05661734