Suzetrigine for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of suzetrigine in easing post-surgery pain, particularly for individuals who might require long-term opioid use. Suzetrigine is a non-opioid pain medication that blocks pain signals without the addiction risks associated with opioids. The trial will compare standard pain treatments to those same treatments plus suzetrigine. Suitable participants include those who have undergone major surgeries, such as hip or knee replacements, and are at high risk of needing long-term opioids. As a Phase 4 trial, suzetrigine has already received FDA approval and proven effective; this research aims to understand its benefits for a broader patient population.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using a fentanyl patch, methadone, or buprenorphine.
What is the safety track record for suzetrigine?
Research has shown that suzetrigine is generally safe and well-tolerated in people. One study found that suzetrigine effectively managed moderate to severe sudden pain, with most patients experiencing good to excellent results. Importantly, the safety review identified no serious side effects linked to its use. Another study highlighted that suzetrigine does not carry the risks associated with opioids, such as addiction or breathing problems, and it also avoids the kidney and stomach bleeding risks linked to NSAIDs (non-steroidal anti-inflammatory drugs). These findings suggest that suzetrigine offers a promising option for pain relief without the usual side effects of traditional pain medications.12345
Why are researchers enthusiastic about this study treatment?
Unlike the standard treatments for postoperative pain, which typically include opioids, NSAIDs, and acetaminophen, Suzetrigine is unique because it targets the Nav1.8 sodium channel in peripheral pain-sensing nerves. This selective sodium channel blocker is the first new class of pain medication in decades. What makes Suzetrigine truly exciting is that it doesn’t carry the risks associated with opioids, like respiratory depression and addiction, nor does it have the kidney or gastrointestinal risks linked with NSAIDs. This means it could offer effective pain relief without the common side effects of current pain management options.
What is the effectiveness track record for suzetrigine in treating postoperative pain?
Research has shown that suzetrigine effectively manages pain after surgery. In one study, 90.9% of patients rated its effectiveness as excellent, very good, or good. In this trial, participants in one arm will receive suzetrigine alongside standard care. Suzetrigine blocks a specific part of the body's pain pathway, providing relief without the addiction risk associated with opioids. Another study found that patients taking suzetrigine experienced faster pain relief and had less nausea and vomiting compared to those taking a placebo. Overall, suzetrigine offers significant pain relief with fewer side effects than traditional pain medications like opioids.16789
Who Is on the Research Team?
Rodney A Gabriel, MD, MAS
Principal Investigator
University of California, San Diego
Are You a Good Fit for This Trial?
This trial is for adults having orthopedic surgery who are at high risk of needing opioids for more than 3 months after their operation, as predicted by a special computer model using their health records.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either standard care or standard care combined with a 14-day regimen of suzetrigine
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain and opioid consumption at multiple time points
What Are the Treatments Tested in This Trial?
Interventions
- Suzetrigine
Trial Overview
The study compares standard pain care (usual opioid prescriptions) to standard care plus suzetrigine, a non-opioid pain medicine taken before and for 14 days after surgery. Participants are randomly assigned to one group or the other.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Suzetrigine is a selective sodium channel blocker, specifically targeting the Nav1.8 sodium channel found in peripheral pain-sensing nerves. Suzetrigine has been FDA approved for acute pain management for moderate-to-severe acute pain (e.g., post-surgical pain) and represents the first new class of pain medication in decades. Compared to opioids, there is no risk of respiratory depression, no associated euphoria (thus lower addiction risk), and does not act on the opioid receptors. Compared to NSAIDs, it has no kidney or GI bleeding risk or effects on the platelets. For participants randomized to this arm, they will receive 100mg po once preoperatively (approximately 1 - 2 hours prior to surgery) in the preoperative holding area. They will then receive 14 days 50mg po twice a day (first dose to start the evening of postoperative day 0. In addition, the participants will receive standard outpatient analgesic prescribing per their surgical provider.
Participants in this group will receive standard outpatient analgesic prescribing (combination of opioids, NSAIDs, acetaminophen) per their surgical provider. No placebo pill will be administered.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Wellcome Leap Inc.
Industry Sponsor
Citations
The effectiveness and value of suzetrigine for moderate ... - PMC
Patients receiving suzetrigine after bunionectomy showed delayed pain relief (longer time to a drop of ≥2 points on the NPRS) than observed in the ...
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consultqd.clevelandclinic.org
consultqd.clevelandclinic.org/suzetrigine-a-new-nonopioid-option-for-acute-painPromise and Practical Limits of Suzetrigine - Consult QD
Suzetrigine also showed faster time to perceptible pain relief (≥ 1-point reduction); greater responder rates at 12, 24 and 48 hours; and higher ...
Suzetrigine (VX-548) for Postoperative Pain
Of these participants, 182 (82.0%) rated Suzetrigine's effectiveness as good, very good, or excellent. This high satisfaction rate suggests that ...
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 ...
NCT07195669 | RCT: Suzetrigine vs Norco for Post-op Pain
This study aims to further evaluate the efficacy and safety of Journavx in managing post-operative pain after third molar removal and orthognathic surgery.
Suzetrigine: A Novel Non-Opioid Analgesic for Acute Pain ...
This review synthesizes current evidence on suzetrigine's mechanism of action, clinical efficacy, safety profile, and therapeutic potential.
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.
Suzetrigine in moderate to severe acute pain: a profile of its use
After treatment, 83.2% of patients rated their perception of the effectiveness of suzetrigine in managing pain as good, very good, or excellent ...
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 ...
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