Suzetrigine for Acute Pain

No longer recruiting at 11 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 abdominoplasty, 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 (SUZ) for managing pain after a tummy tuck (abdominoplasty). It evaluates how well Suzetrigine works and its safety compared to a common pain reliever, hydrocodone with acetaminophen, or a placebo (a pill with no active medicine). People scheduled for a standard tummy tuck and able to take oral medications after surgery might be suitable candidates. The trial aims to find better ways to manage post-surgery pain safely and effectively. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to help bring a new pain management option to market.

Will I have to stop taking my current medications?

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

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

Previous studies found Suzetrigine to be safe and generally well-tolerated, with no serious side effects linked to the treatment. Common mild side effects included itching, muscle spasms, and rashes.

For VX-548, trial evidence suggests it is also well-tolerated. Some participants reported mild side effects such as headaches, nausea, constipation, and dizziness, most of which were not severe.

Both treatments have demonstrated a good safety profile in past research, which is promising for their use in managing pain. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Suzetrigine is unique because it targets acute pain following an abdominoplasty with a novel mechanism. Unlike standard pain management options like hydrocodone/acetaminophen, which are opioid-based and come with the risk of addiction, Suzetrigine offers a non-opioid alternative. This is exciting for researchers because it could manage pain effectively without the side effects and dependency issues associated with opioids. Additionally, the dosing method—starting with a 100 mg dose followed by 50 mg every 12 hours—suggests it might provide consistent relief over 48 hours, offering a potentially smoother pain management experience.

What evidence suggests that this trial's treatments could be effective for acute pain after an abdominoplasty?

Research shows that Suzetrigine is a promising option for reducing moderate-to-severe sudden pain. Studies have found that Suzetrigine, a medication that blocks certain pain signals in the body, effectively reduced pain after surgeries like tummy tucks and bunion removals compared to a placebo. It has demonstrated modest effectiveness, meaning it can help ease pain to some extent. Participants in this trial may receive either Suzetrigine or a matched placebo.

Similarly, VX-548, another treatment studied in this trial, has also shown positive results. Research indicates that VX-548, especially at higher doses, significantly reduced sudden pain for 48 hours after surgeries like tummy tucks. Participants may receive either VX-548 or a matched placebo. These findings suggest that both treatments have shown some effectiveness in managing post-surgical pain. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Inclusion Criteria

Before Surgery: Participant scheduled to undergo a standard ('full') abdominoplasty procedure

After Surgery: Participant is lucid and able to follow commands and able to swallow oral medications

After Surgery: All analgesic guidelines were followed during and after the abdominoplasty

Exclusion Criteria

Before Surgery: Prior history of abdominoplasty

After Surgery: Participant had a non standard abdominoplasty, collateral procedures during the abdominoplasty or any surgical complications during the abdominoplasty

Before Surgery: History of Intra-abdominal and/or pelvic surgery that resulted into complications

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HB/APAP
• Placebo (matched to HB/APAP)
• Placebo (matched to VX-548)
• VX-548

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 48 hours.

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 48 hours.

Group III: Placebo Placebo Group 2 Interventions

Participants received placebo matched to Suzetrigine (SUZ) and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 48 hours.

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. 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.

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

More Data on Suzetrigine, a Novel Nonopioid Pain ... Results from phase 3 trials support modest efficacy for reducing postoperative pain. Suzetrigine, a selective sodium-channel blocker that ...

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

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

4. 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 ...

5. journavxhcp.com journavxhcp.com/clinical-trials

Efficacy and Clinical Trials | JOURNAVX® (suzetrigine) What was measured. The primary endpoint in both trials was JOURNAVX superiority vs placebo on the time-weighted sum of the pain intensity difference (SPID) as ...

6. journavxhcp.com journavxhcp.com/safety

Safety Profile | JOURNAVX® (suzetrigine) JOURNAVX safety data were collected from 2 pooled, double-blind, placebo- and HB/APAP–controlled trials that enrolled 874 patients with moderate-to-severe ...

7. 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.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/219209s000lbl.pdf

JOURNAVX (suzetrigine) tablets, for oral use. The safety profile of JOURNAVX was also evaluated by the following subgroup analyses: age (≥ 18 to < 65 years and. ≥ 65 years), sex, and race.

9. file.medchemexpress.com file.medchemexpress.com/batch_PDF/HY-148800/Suzetrigine-SDS-MedChemExpress.pdf

Safety Data Sheet 7.1 Precautions for safe handling​​ Avoid inhalation, contact with eyes and skin. Avoid dust and aerosol formation.

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

Suzetrigine, a Non-Opioid NaV1.8 Inhibitor With Broad ... Suzetrigine was safe and well tolerated; there were no serious adverse events considered by the investigators to be related to suzetrigine.