Suzetrigine vs Norco for Post-op Pain

Overseen By James Vegryzn, DDS, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Jacob Lensing

Must not be taking: Analgesics

Disqualifiers: Pregnant, Opioid abuse, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 3

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new non-opioid pain medication, suzetrigine, to evaluate its effectiveness in managing pain after certain dental and jaw surgeries. The goal is to determine if suzetrigine can match the effectiveness of opioids, like Norco, without the risks of addiction and other side effects. Participants will receive either suzetrigine with ibuprofen or an opioid with ibuprofen to compare their effectiveness. Suitable candidates have had their lower wisdom teeth removed or are undergoing jaw realignment surgery, provided they do not have certain health conditions or chronic pain issues. As a Phase 4 trial, suzetrigine has already received FDA approval and proven effective, and this research aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are currently using pain medications for another condition, you may not be eligible to participate.

What is the safety track record for Suzetrigine?

A study found that suzetrigine effectively reduced moderate-to-severe pain after surgeries such as tummy tucks and foot surgeries. Research shows that suzetrigine might cause fewer side effects than opioids. Over 83% of participants taking suzetrigine rated their pain relief as "good" to "excellent."

The FDA has approved suzetrigine for managing acute pain, indicating it has passed safety tests for similar uses. Overall, suzetrigine appears well-tolerated with fewer side effects compared to opioids. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Suzetrigine is unique because it offers a non-opioid approach to managing post-operative pain. Unlike traditional treatments like hydrocodone/acetaminophen, which can lead to dependency, suzetrigine's active ingredient, Journavx, aims to provide effective pain relief while minimizing the risk of addiction. Researchers are excited about suzetrigine because it targets pain differently, potentially reducing the need for opioids and their associated side effects. This could represent a significant advancement in post-operative care, offering patients a safer alternative for pain management.

What evidence suggests that Suzetrigine might be an effective treatment for post-operative pain?

This trial will compare suzetrigine with an opioid-based treatment for post-operative pain management. Research has shown that suzetrigine, a non-opioid pain reliever, effectively manages moderate to severe pain after surgery. Studies indicate that suzetrigine significantly reduces pain for 48 hours following surgeries like tummy tucks or bunion removals. Specifically, patients reported an average pain reduction of about 3 points on a 0-to-10 scale. Suzetrigine targets a specific part of the body's pain signal system, helping to avoid side effects often seen with opioids, such as breathing problems or addiction. Overall, suzetrigine provides strong pain relief with fewer risks compared to traditional opioid treatments. ^{1 2 3 6 7}

Who Is on the Research Team?

Jacob Lensing, DDS

Principal Investigator

LSUHSC

Are You a Good Fit for This Trial?

This trial is for adults aged 18-45 who are undergoing lower third molar extraction or orthognathic surgery. Candidates should not have autoimmune diseases, chronic kidney or liver disease, chronic pain disorders including TMJ disorder, bleeding disorders, and must not be pregnant or nursing.

Inclusion Criteria

I am between 18 and 45 years old and will have surgery to correct my jaw alignment.

I am 18-45 years old and need my wisdom teeth removed.

Exclusion Criteria

Cannot receive instruction in English

Pregnant or nursing

History of prior opioid abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either suzetrigine or opioid treatment along with ibuprofen for managing post-operative pain

1 week

1 visit (in-person) for surgery, followed by home administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain assessment and adverse effects

1 week

2 visits (in-person or virtual) for follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Suzetrigine

Trial Overview The study compares Suzetrigine (a non-opioid analgesic targeting a specific sodium channel involved in pain transmission) with Norco (an opioid), to manage post-operative pain after dental surgeries. It aims to assess the effectiveness and safety of Suzetrigine as an alternative to opioids.

How Is the Trial Designed?

Group I: Suzetrigine + Ibuprofen Experimental Treatment 1 Intervention

\- Group 1 will receive a 100-mg oral loading dose of Journavx (suzetrigine), followed by a 50-mg maintenance dose every 12 hours (the high-dose group) and ibuprofen 800 mg q8h for 72 hours after surgery (1).

Group II: Opioid + Ibuprofen Active Control 1 Intervention

\- Group 2 will receive ibuprofen 800 mg x 15 tabs q8h scheduled and hydrocodone/acetaminophen 5/325 q8h PRN for 72 hours after surgery. Patients will be informed not to exceed 3g of acetaminophen or 3200 mg ibuprofen (1).

Who Is Running the Clinical Trial?

Jacob Lensing

Lead Sponsor

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40117446/

Suzetrigine, a Nonopioid Na V 1.8 Inhibitor for Treatment of ... Conclusions: As compared with placebo, suzetrigine reduced moderate-to-severe acute pain over 48 h after abdominoplasty or bunionectomy. Pain ...

2. jmcp.org jmcp.org/doi/10.18553/jmcp.2025.31.7.729

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 ...

3. jwatch.org jwatch.org/na59066/2025/08/14/more-data-suzetrigine-novel-nonopioid-pain-medication

More Data on Suzetrigine, a Novel Nonopioid Pain ... Baseline pain scores averaged 7 on a 0-to-10 scale. By 48 hours after surgery, suzetrigine led to an average pain reduction of ≈3 points versus ...

4. bjanaesthesia.org.uk bjanaesthesia.org.uk/article/S0007-0912(25)00375-7/fulltext

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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12372998/

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 ...

6. asra.com asra.com/news-publications/asra-newsletter/newsletter-item/asra-news/2025/11/09/suzetrigine-as-a-non-opioid-analgesic--balancing-promise-with-prudence

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 ...

7. secure.medicalletter.org secure.medicalletter.org/TML-article-1723a

Suzetrigine (Journavx) — A Sodium Channel Blocker for ... Efficacy: In two 48-hour double-blind trials in adults with moderate to severe acute postoperative pain, suzetrigine was more effective than ...