VX-548 for Acute Pain

No longer recruiting at 14 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: Previous surgery complications, others

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

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: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new drug, VX-548, for treating acute pain. The goal is to determine if it quickly and safely reduces pain in individuals with moderate or severe pain from surgery or a new, non-surgical cause. Participants must have a body mass index (BMI) between 18 and 40 and experience significant pain that impacts daily life. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity 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 shows that VX-548 is generally safe for people. Studies have found that side effects are usually mild to moderate, causing discomfort for some but not typically serious. However, little is known about the long-term safety of VX-548, as most studies focus on short-term use. This treatment is in a later stage of clinical trials, indicating it demonstrated a certain level of safety in earlier studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for acute pain, which often involves opioids or non-steroidal anti-inflammatory drugs (NSAIDs), VX-548 is unique because it targets a specific sodium channel called NaV1.8. This approach is exciting because it promises effective pain relief without the risk of addiction associated with opioids. Additionally, VX-548 could offer pain relief with fewer side effects compared to traditional options, making it a potentially safer alternative for managing acute pain. Researchers are particularly hopeful about VX-548's ability to provide rapid relief, which could significantly enhance patient recovery times.

What evidence suggests that VX-548 is effective for acute pain?

Research has shown that VX-548 effectively treats sudden pain. Studies found that taking it as a pill significantly reduces pain levels. At the highest doses, VX-548 lowered pain for 48 hours after surgeries like tummy tucks and bunion removals. VX-548 also significantly reduced pain compared to a placebo, suggesting it could be a promising option for managing sudden pain. Participants in this trial will receive Suzetrigine (SUZ) as the investigational treatment, administered as a 100 mg first dose, followed by 50 mg every 12 hours for up to 14 days or until pain resolves. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults with a BMI between 18.0 and 40.0 who are experiencing new, moderate to severe acute pain, rated ≥4 on the numeric scale. It includes both surgical patients with postoperative pain and non-surgical individuals with new pain not related to any known condition.

Inclusion Criteria

Your body mass index (BMI) is between 18.0 and 40.0.

If you had surgery, and you have moderate or severe pain at the surgery site, and the pain is rated 4 or higher on a scale.

Your body mass index (BMI) is between 18 and 40.

Exclusion Criteria

If you had surgery for the same problem before, you can join only if the previous surgery was on the opposite limb or organ.

Surgical participants with 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

Surgical participants with 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive VX-548 every 12 hours for up to 14 days

2 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 is testing VX-548's safety and effectiveness in treating acute pain. Participants will receive VX-548 under controlled conditions to assess how well it manages their pain symptoms.

How Is the Trial Designed?

Group I: Suzetrigine (SUZ) Experimental Treatment 1 Intervention

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.

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

Published Research Related to This Trial

In a pilot survey of 22 older adults with chronic pain, gastrointestinal adverse drug events (ADEs) were the most commonly reported, with upset stomach being the most frequent issue, affecting 31.8% of participants.

Many older adults self-manage their analgesic-related ADEs without consulting their healthcare provider; 54.5% contacted their physician, while others changed their medication or stopped taking it altogether, highlighting the need for better communication about ADE management in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Adults' Response to Analgesic Adverse Drug Reactions: A Pilot Study. McDonald, DD., Coughlin, S., Jin, C.[2019]

A systematic review of 80 randomized controlled trials (RCTs) on noninvasive analgesic treatments revealed that adverse event (AE) reporting was often incomplete, with over 40% of trials not reporting any serious adverse events.

The review highlighted that trials involving participants with pain conditions and those sponsored by industry provided better AE data, indicating a need for improved consistency and thoroughness in AE reporting across all analgesic RCTs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations. Smith, SM., Wang, AT., Katz, NP., et al.[2023]

A study analyzing adverse drug reactions (ADRs) related to weak opioid analgesics from 2011 to 2020 found that tramadol was the most commonly reported drug, particularly affecting young women, with gastrointestinal symptoms being the most frequent.

Serious ADRs were more commonly reported in the Pharmacovigilance database, especially for codeine, but no fatalities were observed, indicating a generally safe profile for weak opioids despite the occurrence of ADRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in adverse drug reactions related to oral weak opioid analgesics in therapeutic use in adults: A 10-year French vigilances retrospective study. Caré, W., Pinel, S., Dufayet, L., et al.[2023]

In a review of 24 Phase I studies involving 430 healthy male volunteers over 5 years, the overall incidence of adverse events was 13.5%, with a higher rate for active drug treatments (15.3%) compared to placebo (7.4%).

Severe adverse events occurred in 20 cases (0.36%), but there were no deaths or life-threatening incidents, indicating that while adverse events are common, they are generally not severe in Phase I trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase one studies: a study in 430 healthy volunteers. Sibille, M., Deigat, N., Olagnier, V., et al.[2019]

Citations

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

VX-548 in the treatment of acute pain These showed that VX-548, when given as an oral loading dose of 100 mg followed by 50 mg 12-hly, significantly decreased pain scores compared ...

2. 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.

3. 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 ...

4. 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.

5. 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.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2025/219209Orig1s000AdminCorres.pdf

219209Orig1s000 - accessdata.fda.gov Vertex plans to conduct two pivotal Phase 3 studies to evaluate the efficacy and safety of VX-548 following bunionectomy and abdominoplasty. A ...