Suzetrigine for Acute Pain

Not currently recruiting at 16 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: Previous Suzetrigine, 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 Suzetrigine, a new treatment for managing acute pain after surgeries such as keyhole (laparoscopic) or joint (arthroscopic) procedures. The trial aims to evaluate Suzetrigine's effectiveness, safety, and patient tolerance compared to typical opioid pain relief. It suits individuals scheduled for these surgeries who usually require strong pain medication afterward. Those who have previously taken Suzetrigine or a similar drug are not eligible for this study. As a Phase 4 trial, Suzetrigine has already received FDA approval and proven effective, and this research seeks to understand its benefits for more patients.

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.

What is the safety track record for Suzetrigine?

Research has shown that suzetrigine is generally safe and well-tolerated. In a study involving 256 people with moderate to severe sudden pain, common side effects included itching, muscle spasms, elevated muscle enzyme levels, and rash. These side effects were mild and did not affect most patients. Additionally, the FDA has approved suzetrigine for treating sudden pain, indicating its safety. Overall, this treatment appears to be a safe choice for those dealing with sudden pain. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for acute pain, like opioids and NSAIDs, work by blocking pain signals or reducing inflammation. But Suzetrigine stands out because it targets a different pathway, potentially offering relief without the side effects commonly associated with these standard treatments. Researchers are excited about Suzetrigine because it might act faster, providing pain relief in just days, and potentially be safer for long-term use, minimizing risks like dependency and gastrointestinal issues.

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

Research has shown that suzetrigine, which participants in this trial will receive, effectively reduces moderate-to-severe sudden pain. Studies found it provides significant relief, lowering pain by about 3 points on a pain scale within 48 hours after surgery. This is slightly better than a placebo, which reduced pain by about 2 points. Suzetrigine, a non-opioid medication, blocks certain pain signals and does not carry the addiction risk associated with opioids. It has proven safe and effective for treating pain, making it a promising option for managing pain after surgery. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults who've had certain laparoscopic procedures within the intraperitoneal or retroperitoneal cavities, or arthroscopic orthopedic surgeries. Participants must have a BMI between 18.0 and 40.0 kg/m^2.

Inclusion Criteria

My BMI is between 18.0 and 40.0.

I have had a laparoscopic surgery in my abdomen or behind the abdomen.

I am scheduled for or have had a minimally invasive joint surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Suzetrigine (SUZ) for acute pain management for 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) to see how effective and safe it is in managing acute pain following specific minimally invasive surgeries like laparoscopy or arthroscopy.

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

Published Research Related to This Trial

Opioids can be effective and relatively safe options for managing pain, but they are often avoided due to concerns about potential side effects and adverse events.

The side effects of opioids can affect multiple body systems, but with proper management and quick intervention, these effects can be addressed, allowing opioids to be used safely and effectively for pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticipating and treating opioid-associated adverse effects. Herndon, CM., Kalauokalani, DA., Cunningham, AJ., et al.[2019]

A systematic review of nonpharmacologic pain treatment trials revealed significant inadequacies in adverse event (AE) reporting, with less than half of the trials detailing specific AE assessment methods.

AE reporting was more comprehensive in trials involving patients compared to those with healthy volunteers, indicating a need for improved adherence to reporting guidelines across all types of trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review. Hunsinger, M., Smith, SM., Rothstein, D., et al.[2018]

A review of 10 randomized controlled trials on acupuncture for pain relief found that only 6 studies reported adverse events, and most did not adequately detail how these events were collected or assessed.

The findings indicate that acupuncture trials have not fully adhered to the updated CONSORT guidelines for reporting adverse events, highlighting the need for improved documentation to ensure patient safety and better understanding of potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in acupuncture clinical trials focusing on pain. Capili, B., Anastasi, JK., Geiger, JN.[2022]

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]

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.