Suzetrigine for Rib Fractures

Overseen By Peter D Nguyen, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, Irvine

Must not be taking: Strong CYP3A inhibitors, inducers

Disqualifiers: Pregnant, Cirrhosis, Chronic opioid use, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests suzetrigine as a new method to manage pain from rib fractures, aiming to reduce pain and decrease opioid use. Rib fractures can cause significant pain and lead to lung infections, making effective pain control essential. Participants will receive either suzetrigine or a placebo as part of their pain management plan. The trial seeks adults who have experienced blunt trauma, have more than three rib fractures, and can take oral medication. As a Phase 4 trial, suzetrigine is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they are strong CYP3A inhibitors or inducers, as these are not allowed in the trial. If you're on any of these medications, you should discuss with the trial team to see if adjustments are needed.

What is the safety track record for suzetrigine?

Research has shown that suzetrigine is generally safe and well-tolerated in people. In a study with 256 participants, suzetrigine, a non-opioid pain reliever, proved safe for those experiencing various types of pain, including pain from surgery and other causes. This study reported no major safety issues.

Suzetrigine has also completed at least one previous human trial successfully, indicating its safety. While still under testing for use in rib fractures, current evidence suggests it is a promising and safe option for managing sudden pain. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for rib fractures, which often involve pain management with opioids or NSAIDs, suzetrigine is unique because it directly targets the pain pathway with its novel mechanism of action. This investigational drug is designed to offer relief by modulating nerve signals involved in pain perception, potentially reducing the reliance on traditional pain medications that can have significant side effects. Researchers are excited about suzetrigine because it offers a new, targeted approach that could provide effective pain relief with fewer risks and side effects compared to current options.

What evidence suggests that suzetrigine might be an effective treatment for rib fractures?

Research shows that suzetrigine effectively treats sudden pain from broken ribs. In this trial, participants in the suzetrigine arm will receive oral suzetrigine, while those in the control arm will receive placebo capsules. Studies have found that adding suzetrigine to regular pain treatments can improve pain relief and reduce the need for opioids, which are strong painkillers often used for severe pain. Clinical data suggest that suzetrigine manages pain better than standard treatments alone. This medication has also been effective for pain in other conditions, indicating it could work well for rib fractures too. Overall, suzetrigine appears to be a promising option for better pain control in patients with rib fractures. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for patients with painful broken ribs. It's open to those who can take part in a multimodal pain regimen, which includes various medications like acetaminophen and NSAIDs. The exact eligibility criteria aren't provided, but typically participants must be adults and not have conditions that could interfere with the study or pose risks.

Inclusion Criteria

I am older than 18 years.

I can eat and drink without assistance.

I have more than 3 broken ribs.

Exclusion Criteria

Pregnant

Rhabdomyolysis (CPK > 5,000 U/L)

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral suzetrigine or placebo for pain management during hospitalization

Up to 2 years

Daily monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment, including mortality and respiratory complications

30 days post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• Suzetrigine

Trial Overview

The trial tests Suzetrigine (SUZ), added to standard pain relief methods, against a placebo to see if it better manages acute pain from rib fractures and reduces opioid use. Participants will randomly receive either SUZ or an inactive substance alongside their regular pain treatment.

How Is the Trial Designed?

Group I: Suzetrigine arm Experimental Treatment 1 Intervention

The intervention arm will receive oral suzetrigine (100 mg loading dose followed by 50 mg every 12 hours).

Group II: Control arm Placebo Group 1 Intervention

The control arm will receive placebo capsules matched to suzetrigine for oral administration.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07145346

Suzetrigine for Acute Pain Control in Patients With Multiple ...

However, suzetrigine is a promising alternative to treat acute pain associated with rib fractures. We think the addition of suzetrigine to a multimodal pain ...

2.

clinicaltrials.icts.uci.edu

clinicaltrials.icts.uci.edu/trial/NCT07145346

UC Irvine Rib Fracture Trial → Suzetrigine for Acute Pain ...

However, suzetrigine is a promising alternative to treat acute pain associated with rib fractures. We think the addition of suzetrigine to a multimodal pain ...

3.

withpower.com

withpower.com/trial/phase-4-rib-fractures-7-2025-a0391

Suzetrigine for Rib Fractures · Info for Participants

We think the addition of suzetrigine to a multimodal pain regimen will improve pain and decrease opioid use.

4.

go.drugbank.com

go.drugbank.com/conditions/DBCOND0005395

Rib Fractures (DBCOND0005395)

Associated Data ; NCT01327287. Early Aggressive Pain Management is Associated With Improved Outcomes in Blunt Thoracic Trauma, No drug interventions ; NCT06222333.

5.

icer.org

icer.org/wp-content/uploads/2025/02/ICER_Acute-Pain_Evidence-Report_For-Publication_020525.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 ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40165940/

Suzetrigine, a Non-Opioid Na V 1.8 Inhibitor With Broad ...

Results: Suzetrigine was generally safe and well-tolerated in participants (N=256) with a range of surgical and non-surgical acute pain ...