235 Participants NeededMy employer runs this trial

Suzetrigine for Postoperative Pain

(SMOOTH-SURG Trial)

HB
ML
Overseen ByMichael Lazar, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Icahn School of Medicine at Mount Sinai
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Suzetrigine to determine if it can reduce the need for opioids and lessen pain after weight-loss or heart surgery. Participants will receive either Suzetrigine or a placebo (a pill with no active medicine) to compare results. Ideal candidates for this study are those scheduled for weight-loss surgery or heart surgery through the chest. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking pain management solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are taking certain medications that affect liver enzymes, like some antibiotics and seizure medications. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that Suzetrigine is likely to be safe for humans?

Research has shown that Suzetrigine is generally safe and well-tolerated. Studies have found it effectively manages pain with few side effects. Most reported side effects are mild or moderate, such as nausea or dizziness. Importantly, no serious adverse events have been linked to Suzetrigine.

In one study, 90.9% of patients recovered without needing opioids, highlighting its potential as a non-opioid pain relief option. The FDA has approved the treatment for other uses, which supports its safety. Overall, Suzetrigine appears to be a promising option for reducing postoperative pain with minimal risk.12345

Why do researchers think this study treatment might be promising for postoperative pain?

Researchers are excited about Suzetrigine for postoperative pain because it offers a potentially new way to manage pain after surgery. Unlike standard treatments like opioids or NSAIDs, which come with risks of addiction and side effects, Suzetrigine is being explored as a non-opioid alternative. This treatment works by targeting specific pain pathways, which may lead to effective pain relief with fewer risks. Additionally, its administration in the form of oral pills could make it more convenient for patients compared to some current options.

What evidence suggests that Suzetrigine might be an effective treatment for postoperative pain?

Research has shown that Suzetrigine is a promising option for managing post-surgical pain. In this trial, participants undergoing bariatric or cardiac surgery will receive either Suzetrigine or a placebo to evaluate its effectiveness. Studies have found that Suzetrigine can effectively control pain, with nearly 91% of patients avoiding opioids while still achieving good pain relief. Specifically, in trials for tummy tuck surgeries, 68% of patients reported good or excellent pain control after 48 hours, compared to 50% in the placebo group. Suzetrigine blocks certain pain signals in the body, providing relief without the need for opioids. Overall, the evidence suggests that Suzetrigine may help reduce pain and the need for opioids after surgery.46789

Who Is on the Research Team?

HB

Himani Bhatt, DO

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 who are scheduled for weight-loss (bariatric) or open-heart surgery. People can't join if they have severe health issues, use certain medications, have a history of substance abuse or chronic opioid use, need urgent surgery, or can't give consent.

Inclusion Criteria

I am between 18 and 85 years old.
I am scheduled for heart surgery through the chest or weight loss surgery.
My gender does not affect my eligibility.

Exclusion Criteria

ASA Class V
I am unable or unwilling to give my consent to participate.
History of substance use disorder or chronic opioid use
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Suzetrigine or placebo pre-operatively and every 12 hours post-operatively for 5 days

5 days
Daily monitoring

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 tests whether adding Suzetrigine to standard pain management after bariatric or heart surgery can reduce the need for opioids and lower pain levels. Participants are randomly assigned to receive either Suzetrigine or a placebo.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Cardiac SuzetrigineExperimental Treatment1 Intervention
Group II: Bariatric SuzetrigineExperimental Treatment1 Intervention
Group III: Bariatric PlaceboPlacebo Group1 Intervention
Group IV: Cardiac PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

Citations

The effectiveness and value of suzetrigine for moderate ... - PMC

In the bunionectomy trial, suzetrigine treatment resulted in less pain relief than HB5/APAP325 on the SPID48 (LSMD = −20.2; 95% CI = −32.7 to −7.7; P = 0.0016).

Association of Suzetrigine With Postoperative Outcomes ...

A novel non-opioid analgesic, Suzetrigine, may be able to effectively manage postoperative pain without some of the psychological and economic ...

Data Support Suzetrigine's Use for Acute Pain Following ...

Phase 4 data show suzetrigine controls post–plastic surgery pain, keeping nearly 91% of patients opioid free with good pain ratings and ...

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 ...

Suzetrigine: a novel non-opioid for acute postoperative pasin ...

In the abdominoplasty trial, 68% of suzetrigine-treated patients reported good or excellent pain control at 48 hours, compared to 50% of placebo ...

Clinical Efficacy and Safety Profile of Suzetrigine: A Novel Non ...

These randomized, double-blind studies assessed the analgesic efficacy of suzetrigine in postoperative pain management following bunionectomy ...

Pain Suzetrigine Data Reveal Reduced Postoperative ...

SALT LAKE CITY—New data show that suzetrigine (Journavx, Vertex) results in opioid-free recovery for 90.9% of patients treated with the ...

Safety and efficacy of Suzetrigine (VX-548) for acute ...

Suzetrigine shows strong efficacy and a favorable safety profile in acute post-surgical and neuropathic pain. •. Suzetrigine significantly reduces the risk of ...

Suzetrigine for acute postoperative pain: a systematic ...

In conclusion, suzetrigine appears to offer effective perioperative analgesia with a favourable safety profile. Although further research is needed to confirm ...