Suzetrigine for Pain After Mohs Surgery

Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Baylor Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 two medications to determine which better manages pain after Mohs surgery, a type of skin cancer surgery. Participants will take either suzetrigine, a new potential drug, or the standard pain medication Norco, which combines hydrocodone and acetaminophen. The trial aims to find effective pain relief options for individuals who have undergone this specific dermatologic surgery. Ideal participants are adults who have had a skin tumor removed through Mohs surgery. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and it seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

If you are taking medications that interact with the CYP3A pathway, you will need to stop them to participate in this trial.

What is the safety track record for these treatments?

Research has shown that suzetrigine is generally safe. Studies have found it causes fewer common side effects, such as nausea and dizziness, compared to other pain medications. Most people using suzetrigine do not require additional painkillers. The drug is considered safe and well-tolerated, with only mild or moderate side effects reported. Trials have not observed any serious side effects. The FDA has also approved suzetrigine for treating sudden pain, indicating trust in its safety for this purpose.12345

Why are researchers enthusiastic about this study treatment?

Most treatments for pain after Mohs surgery, like Norco, rely on a combination of hydrocodone and acetaminophen to manage discomfort. But Suzetrigine works differently, as it targets pain through a unique mechanism that researchers believe could reduce dependency on opioids. This novel approach not only aims to manage pain effectively but also addresses concerns related to opioid use, making Suzetrigine an exciting potential alternative in post-surgical pain management.

What evidence suggests that this trial's treatments could be effective for pain after Mohs surgery?

Research has shown that suzetrigine effectively manages post-surgical pain. In this trial, participants will receive either suzetrigine or the standard care drug, Norco, which combines hydrocodone and acetaminophen. Studies have found that suzetrigine offers pain relief comparable to opioids like hydrocodone but with fewer side effects, such as nausea and vomiting. Most patients rated suzetrigine as providing good to excellent pain relief. It targets pain pathways without the risks associated with opioids. Overall, suzetrigine represents a promising non-opioid option for reducing pain after surgery.678910

Who Is on the Research Team?

ST

Stan Tolkachjov, MD

Principal Investigator

Baylor Medical University Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 89 who are having Mohs surgery to remove a skin tumor. People outside this age range or not undergoing this type of surgery cannot participate.

Inclusion Criteria

I am between 18 and 89 years old.
I have had a skin tumor treated with Mohs surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either suzetrigine or hydrocodone/acetaminophen for postoperative pain management following Mohs micrographic surgery

48 hours
1 visit (in-person) for surgery and initial treatment

Follow-up

Participants are monitored for safety and effectiveness, including adverse events and pain management efficacy

3 days
Follow-up assessments at 24 and 48 hours post-surgery

What Are the Treatments Tested in This Trial?

Interventions

  • Norco
  • Suzetrigine

Trial Overview

The study compares two pain medications after skin cancer surgery: Suzetrigine and Norco (a combination of hydrocodone and acetaminophen). Participants are randomly assigned to receive one of these treatments.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: ControlActive Control1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials
210
Recruited
205,000+

Citations

Suzetrigine as a Novel Non-opioid Analgesic Drug in Pain ...

Phase II and III clinical trials have demonstrated the high efficacy of suzetrigine in managing postoperative pain, along with good tolerability ...

The effectiveness and value of suzetrigine for moderate ...

Suzetrigine demonstrated superior pain relief compared with placebo in both trials; the least squares mean difference (LSMD) in SPID48 between ...

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

Suzetrigine has also been shown to have comparable analgesia to oral opioids with fewer side effects, such as nausea, vomiting, and need for rescue pain ...

Suzetrigine as a Non-Opioid Analgesic: Balancing Promise ...

Overall, 83.2% of subjects rated suzetrigine as providing “good” to “excellent” analgesia. Comparative Effectiveness. While the data show that ...

Suzetrigine for acute postoperative pain: a systematic ...

Our results suggest that suzetrigine might reduce the overall burden of opioid-related side effects, as reflected by the lower RR of any adverse events compared ...

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

Generally, suzetrigine was observed to be safe and well tolerated with no serious adverse events (AEs). Any reported AEs were mild or moderate ...

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

The drug displayed a favorable safety profile with a lower incidence of common opioid-related adverse effects, such as nausea and dizziness, and ...

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 ...

SUZETRIGINE (VX-548) FOR POSTOPERATIVE PAIN

Clinical trials have shown analgesia through Suzetrigine that is comparable with opioid therapy while maintaining a favorable safety profile and ...

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 ...