VX-548 for Pain

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: Febrile illness, Drug absorption issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how the body metabolizes and tolerates a new treatment called VX-548, an experimental drug. Researchers focus on how different food conditions might affect the drug's absorption and safety in healthy participants. Suitable candidates for this trial should have a body mass index (BMI) between 18 and 35 and weigh over 50 kilograms. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that VX-548 is likely to be safe for humans?

Research has shown that VX-548 is generally safe for people. Most side effects are mild to moderate, with common ones including headaches, nausea, constipation, and dizziness. Studies lasting up to 12 weeks observed these effects. Overall, the treatment appears to have a manageable safety profile based on the available data. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for pain management, such as opioids or NSAIDs, have well-known risks and side effects. But VX-548 works differently, targeting the body's pain pathways in a novel way with the potential to offer relief without the typical drawbacks. Researchers are excited because VX-548 could provide a safer, more effective option by addressing pain through a new mechanism of action. Unlike current options, VX-548 might offer quicker relief with fewer side effects, making it a promising candidate for those seeking alternatives to traditional pain medications.

What evidence suggests that VX-548 is effective?

Research has shown that VX-548, the investigational treatment in this trial, effectively reduces sudden pain. In studies, the highest dose of VX-548 significantly lowered pain levels after surgeries such as tummy tucks (a type of cosmetic surgery) and bunion removal (foot surgery). Other studies have found that all doses of VX-548 lead to noticeable pain relief. This treatment works by specifically blocking a protein called NaV1.8, which is involved in sending pain signals. Early results are promising, especially at higher doses, suggesting it could be a strong option for managing sudden pain. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Body mass index (BMI) of 18.0 to 35.0 kilogram per meter square (Kg/m^2)

A total body weight greater than (>) 50 kilogram (kg)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of VX-548 in 1 of 6 treatment sequences with 3 dosing periods to assess different fed conditions and timing of meal administration

6 weeks

3 visits (in-person)

Washout

A 14-day washout period between each dosing period

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VX-548

How Is the Trial Designed?

Group I: VX-548 Experimental Treatment 1 Intervention

Participants will be randomized to receive a single dose of VX-548 in 1 of 6 treatment sequences with 3 dosing periods to assess different fed conditions and timing of meal administration on the PK of VX 548. There will be a 14 day washout period between each dosing period.

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

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

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37530822/

Selective Inhibition of NaV1.8 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.

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

Vertex Announces Positive Results From Phase 2 Study of ... Treatment with all doses of VX-548 resulted in a statistically significant and clinically meaningful reduction in the primary endpoint of change ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05660538

Evaluation of Efficacy and Safety of VX-548 for Painful ... The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN. Official Title. A Phase 2, Randomized, Double-blind, ...

5. icer.org icer.org/wp-content/uploads/2024/12/ICER_Acute-Pain_Draft-Report_For-Publication_120924.pdf

Suzetrigine for Acute Pain:Effectiveness and Value Vertex Announces Positive Results From the VX-548 Phase 3 Program for the Treatment of Moderate-to-Severe Acute Pain. Accessed September 16 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39552600/

VX-548 in the treatment of acute pain Evidence from Phase II and III trials suggest that VX-548 is well-tolerated, with headache, nausea, constipation and dizziness being the most ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05553366

Evaluation of Efficacy and Safety of VX-548 for Acute Pain ... A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy. Conditions.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2025/219209Orig1s000IntegratedR.pdf

219209Orig1s000 - accessdata.fda.gov Notes: VX-548 is SUZ and M6-548 is M6-SUZ. Solid symbols represent the observed data (mean ± standard deviation) from study. VX21-548-011 and VX-22-548-013 ...