VX-548 for Post-Bunionectomy Pain

No longer recruiting at 20 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vertex Pharmaceuticals Incorporated

Must not be taking: Anti-arrhythmia treatments

Disqualifiers: Prior foot surgery, Cardiac dysrhythmias, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called suzetrigine (also known as VX-548) to determine its safety and effectiveness in reducing pain after bunion surgery. Researchers will compare suzetrigine with a common pain medication (hydrocodone with acetaminophen) and a placebo (a pill with no active drug) over two days. Ideal participants are those undergoing their first bunion surgery on one foot and who have adhered to all pain management guidelines during their procedure. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new pain treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that suzetrigine, also known as VX-548, has been tested for safety in treating sudden pain. In previous studies, suzetrigine was administered to patients after surgeries like tummy tucks and bunion removal. These studies found that suzetrigine is generally well-tolerated compared to a placebo.

No major safety issues arose for suzetrigine during these trials. Patients did not experience serious side effects more often than those who received a placebo, suggesting the treatment is relatively safe for short-term pain relief. However, like any medication, some people might experience mild side effects.

The current phase of the study examines both the effectiveness and safety of suzetrigine, indicating some confidence in its safety based on earlier research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

VX-548 is unique because it targets post-bunionectomy pain differently than traditional opioids like hydrocodone combined with acetaminophen. Unlike opioids, which typically work by binding to opioid receptors in the brain, VX-548 uses a novel mechanism that aims to specifically block pain signals at the source, potentially reducing the risk of common opioid side effects like addiction and sedation. Researchers are excited about VX-548 because it offers the potential for effective pain relief without the heavy reliance on opioids, representing a significant step forward in pain management after surgery.

What evidence suggests that VX-548 might be an effective treatment for post-bunionectomy pain?

Research has shown that suzetrigine, also known as VX-548, effectively reduces moderate-to-severe pain after surgeries like bunion removal. In this trial, participants receiving suzetrigine experienced significantly lower pain levels within 48 hours compared to a placebo. Patients reported a clear decrease in pain, making it a promising choice for managing acute pain. However, some evidence suggests that the onset of pain relief might take a little longer. Overall, suzetrigine appears to be a strong option for managing post-surgery pain without using opioids. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for people who are clear-headed and can follow instructions, scheduled to have a specific type of foot surgery (bunionectomy) under certain anesthesia. They must have followed pain management guidelines before and after surgery. Those with previous foot surgeries, recent heart rhythm problems needing treatment, or any surgery in the last month cannot join.

Inclusion Criteria

Before Surgery

I'm sorry, but the phrase "After Surgery" on its own does not provide enough context for me to accurately summarize the criterion. Can you please provide more details or clarify the specific criterion you'd like me to summarize?

Participant is lucid and able to follow commands

Exclusion Criteria

You have had surgery on the big toe or the foot next to it in the past.

You have had irregular heartbeats in the past 2 years that needed medication to control them.

Any prior surgery within 1 month before the first study drug dose

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either VX-548, HB/APAP, or placebo for acute pain management after bunionectomy

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VX-548

Trial Overview The study tests VX-548's effectiveness and safety in managing acute pain post-bunionectomy compared to HB/APAP (a known pain reliever) and placebos that look like each drug but contain no active ingredients.

How Is the Trial Designed?

Group I: Suzetrigine (SUZ) Experimental Treatment 2 Interventions

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

Group II: Hydrocodone bitartrate/acetaminophen (HB/APAP) Active Control 2 Interventions

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

Group III: Placebo Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

Vertex Pharmaceuticals Incorporated

Lead Sponsor

Trials

267

Recruited

36,100+

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40117446/

Suzetrigine, a Nonopioid Na V 1.8 Inhibitor for Treatment of ... Conclusions: As compared with placebo, suzetrigine reduced moderate-to-severe acute pain over 48 h after abdominoplasty or bunionectomy. Pain ...

2. news.vrtx.com news.vrtx.com/news-releases/news-release-details/vertex-announces-positive-results-vx-548-phase-3-program

Vertex Announces Positive Results From the VX-548 Phase 3 ... Treatment with VX-548 led to statistically significant improvement in pain compared to placebo as well as a clinically meaningful reduction in pain from ...

3. jmcp.org jmcp.org/doi/10.18553/jmcp.2025.31.7.729

The effectiveness and value of suzetrigine for moderate ... Patients receiving suzetrigine after bunionectomy showed delayed pain relief (longer time to a drop of ≥2 points on the NPRS) than observed in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05553366

Evaluation of Efficacy and Safety of VX-548 for Acute Pain ... The purpose of this study is to evaluate the efficacy and safety of suzetrigine for acute pain after a bunionectomy. Official Title. A Phase 3, Randomized ...

5. icer.org icer.org/wp-content/uploads/2025/02/ICER_Acute-Pain_Evidence-Report_For-Publication_020525.pdf

Suzetrigine for Acute Pain:Effectiveness and Value In the bunionectomy trial, patients received randomized treatment within nine hours after resolution of a popliteal sciatic. Page 19. ©Institute ...

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa2209870

Selective Inhibition of Na V 1.8 with VX-548 for Acute Pain VX-548 at the highest dose, but not at lower doses, reduced acute pain over a period of 48 hours after abdominoplasty or bunionectomy.