Suzetrigine for Postoperative Pain

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 aims to evaluate the effectiveness of suzetrigine, a pain medication, when combined with a nerve block to manage pain after breast surgery that is not a mastectomy. Participants will take suzetrigine before their surgery and continue for a few days afterward. The trial seeks individuals undergoing breast surgery who anticipate experiencing at least moderate pain afterward. As a Phase 4 trial, suzetrigine has already received FDA approval and proven effective, and this research seeks to understand its benefits for a broader range of patients.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop using certain medications, like moderate or strong CYP3A inhibitors, a week before and after surgery. If you're using hormonal contraceptives with progestins other than levonorgestrel and norethindrone, you may need to switch to nonhormonal options. Other medications are not specifically mentioned, so check with the trial team for more details.

What is the safety track record for suzetrigine?

Research has shown that suzetrigine is generally safe and easy to handle. Studies have found it causes fewer side effects than other pain medications. For instance, people using suzetrigine after surgeries like a tummy tuck or foot surgery experienced fewer issues such as nausea or vomiting, and most did not require additional pain relief.

In another study, over 90% of patients who took suzetrigine after surgery did not need opioids, which can have more serious side effects. This finding suggests that suzetrigine is a good choice for managing post-surgery pain with fewer risks.12345

Why are researchers enthusiastic about this study treatment?

Suzetrigine is unique because it offers a different approach to managing postoperative pain compared to standard treatments like opioids or nonsteroidal anti-inflammatory drugs (NSAIDs). It is taken orally, starting with a 100 mg dose before surgery, followed by 50 mg doses every 12 hours, which might provide more consistent pain management and potentially reduce the need for opioids, known for their risk of addiction and side effects. Researchers are particularly excited about suzetrigine because it could offer effective pain relief with a potentially better safety profile, making recovery smoother and less risky for patients.

What is the effectiveness track record for suzetrigine in treating postoperative pain?

Research has shown that suzetrigine, the treatment being tested in this trial, effectively manages post-surgical pain. Studies have found it provides significant relief for moderate to severe pain following surgeries like tummy tucks and bunion removals. Notably, 90.9% of patients using suzetrigine recovered without needing opioids, which are strong painkillers. Suzetrigine is a non-opioid medication that blocks certain pathways in the body to reduce pain signals. This makes it a promising choice for those seeking to manage pain without the side effects of opioids.24678

Who Is on the Research Team?

BM

Brian M Ilfeld, MD, MS

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for adults (18+) having breast surgery that isn't a mastectomy and is expected to cause moderate or more pain. Participants must be getting a single-injection nerve block. People with recent opioid use, certain medication use, pregnancy, severe kidney or liver problems, or who can't stay in contact with the study team cannot join.

Inclusion Criteria

I am having breast surgery that is expected to cause moderate or more pain.
I am at least 18 years old.
I am scheduled to have a single injection nerve block.

Exclusion Criteria

History of opioid misuse or dependence
I have used opioids or tramadol daily for more than 4 weeks recently.
I have nerve or brain problems in the area where surgery is planned.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative

Participants receive the first dose of suzetrigine and undergo standard preoperative procedures including paravertebral nerve block

1 day
1 visit (in-person)

Postoperative Treatment

Participants take suzetrigine tablets every 12 hours through the evening of postoperative day 2, with pain management and monitoring

3 days
Daily telephone calls

Follow-up

Participants are monitored for pain and opioid consumption, with data collection via telephone calls

7 days
Daily telephone calls

Long-term Follow-up

Participants are assessed for chronic pain and other outcomes at 6 months post-surgery

6 months
1 telephone call

What Are the Treatments Tested in This Trial?

Interventions

  • Suzetrigine

Trial Overview

The study tests suzetrigine, an FDA-approved pain medicine, given after non-mastectomy breast surgery along with a one-time paravertebral nerve block to see how well it controls post-surgery pain.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Experimental: SuzetrigineExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

Vertex Pharmaceuticals Incorporated

Industry Sponsor

Trials
267
Recruited
36,100+
Dr. David Altshuler profile image

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani profile image

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology

Citations

1.

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.

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 ...

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 ...

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 ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41222511/

Efficacy and Safety of Suzetrigine for Acute Postoperative ...

These findings suggest that suzetrigine offers effective and well-tolerated analgesia, supporting its role in opioid-sparing postoperative pain ...

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 ...

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 ...

Efficacy and Safety of Suzetrigine for Acute Postoperative ...

This systematic review and meta-analysis aimed to assess the efficacy and safety of suzetrigine compared to placebo in adults with acute postoperative pain. A ...