Suzetrigine for Acute Pain

Not currently recruiting at 4 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: Previous SUZ study, Journavx, others

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

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 how well Suzetrigine manages acute pain after surgery. Researchers aim to determine its safety, effectiveness, and tolerability within a broader pain management plan. Ideal participants are those scheduled for surgery typically requiring strong pain medications, such as opioids, for at least three days afterward. Those who have previously participated in a Suzetrigine trial or used a medication called Journavx are not eligible. As a Phase 4 trial, Suzetrigine is already FDA-approved and proven effective; this research seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

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

What is the safety track record for Suzetrigine?

Research has shown that suzetrigine is generally safe and well-tolerated. In a study with 256 participants experiencing various types of sudden pain, common side effects included itching, muscle spasms, elevated enzyme levels in the blood, and rash. These mild side effects are usually not serious.

Suzetrigine is approved for treating moderate to severe sudden pain, indicating sufficient study to consider it safe in certain situations. However, discussing any concerns with the trial team or a doctor is always important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for acute pain, which often involve opioids or non-steroidal anti-inflammatory drugs (NSAIDs), Suzetrigine targets pain differently. Researchers are excited about Suzetrigine because it offers a novel approach by potentially reducing pain more quickly and effectively. This new drug might also come with fewer side effects compared to traditional pain medications, making it a promising option for those who need fast relief without the typical drawbacks of current treatments.

What is the effectiveness track record for Suzetrigine in treating acute pain?

Research shows that Suzetrigine, which participants in this trial will receive, effectively treats moderate-to-severe sudden pain. Studies have found that it significantly reduces pain compared to a placebo. Specifically, 48 hours after surgery, patients taking Suzetrigine reported an average pain reduction of about 3 points on a pain scale, while those taking a placebo reported about a 2-point reduction. Additionally, as a non-opioid, Suzetrigine does not carry the addiction risk associated with some pain medications. Experts agree on its safety and effectiveness, making it a promising choice for managing sudden pain after surgery. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with a BMI of 18.0 to 40.0 kg/m^2 who are scheduled for aesthetic or reconstructive surgery, normally treated with opioids post-surgery. It's not specified who can't join the trial.

Inclusion Criteria

I am scheduled for surgery that usually requires opioids for pain management for at least 3 days afterwards.

My BMI is between 18.0 and 40.0.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Suzetrigine (SUZ) as part of multimodal therapy for up to 14 days or until pain resolves

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Suzetrigine

Trial Overview The study is testing Suzetrigine (SUZ) as part of a multimodal therapy approach to manage acute pain after certain surgeries, aiming to assess its effectiveness and safety.

How Is the Trial Designed?

Group I: Suzetrigine (SUZ) Experimental Treatment 1 Intervention

Participants will receive SUZ for 14 days or until their 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

Citations

1. icer.org icer.org/wp-content/uploads/2025/03/ICER_Acute-Pain_Final-Report_For-Publication_033125.pdf

Suzetrigine for Acute Pain:Effectiveness and Value We aimed to assess the clinical effectiveness and safety of suzetrigine as an add-on to non-systemic treatments for patients with moderate to ...

2. jmcp.org jmcp.org/doi/10.18553/jmcp.2025.31.7.729

The effectiveness and value of suzetrigine for moderate ... We evaluated the efficacy and safety of suzetrigine in adults with moderate to severe acute pain against 4 treatment modalities.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11955400/

Suzetrigine, a Non-Opioid NaV1.8 Inhibitor With Broad ... Suzetrigine provides a safe and effective non-opioid, non-addictive treatment with broad applicability for moderate-to-severe acute pain.

4. jwatch.org jwatch.org/na59066/2025/08/14/more-data-suzetrigine-novel-nonopioid-pain-medication

More Data on Suzetrigine, a Novel Nonopioid Pain ... By 48 hours after surgery, suzetrigine led to an average pain reduction of ≈3 points versus ≈2 points with placebo. Suzetrigine provided similar ...

5. investors.vrtx.com investors.vrtx.com/news-releases/news-release-details/vertex-announces-results-phase-2-study-suzetrigine-treatment

Vertex Announces Results From Phase 2 Study of ... The study met its primary endpoint with statistically significant and clinically meaningful reduction in pain on the numeric pain rating scale (NPRS).

6. journavx.com journavx.com/safety-side-effects

Safety and Side Effects | JOURNAVX® (suzetrigine) The most common side effects for patients treated with JOURNAVX included itching, muscle spasms, increased blood level of creatine phosphokinase, and rash.

7. fda.gov fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain

FDA Approves Novel Non-Opioid Treatment for Moderate ... ... safety data from one single-arm, open-label study in 256 participants with moderate to severe acute pain in a range of acute pain conditions.