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Suzetrigine + Efavirenz for Pain Management

MI
Overseen ByMedical Information
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Vertex Pharmaceuticals Incorporated
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the new drug Suzetrigine (SUZ) functions in the body both alone and in combination with another medicine, efavirenz. The researchers aim to understand how the body processes SUZ and to assess its safety and tolerability. Participants will take SUZ alone for the first two weeks, followed by both SUZ and efavirenz for the next two weeks. The trial seeks generally healthy individuals with a BMI between 18 and 32 and a weight of more than 50 kg. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new drug.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Suzetrigine and Efavirenz are likely to be safe?

Research has shown that suzetrigine is generally safe for treating sudden pain. In previous studies, patients who took suzetrigine experienced significant improvement compared to those who took a placebo, and it was safe for short-term use. However, the long-term safety of suzetrigine remains under investigation.

Efavirenz is primarily used to treat HIV, and its safety profile is well-established. The combination of suzetrigine and efavirenz is new, making this trial crucial for understanding their interaction and safety. As a Phase 1 trial, the primary focus is on safety and tolerability, with researchers closely monitoring for any side effects.12345

Why are researchers excited about this trial's treatments?

Unlike the standard of care for pain management, which often involves opioids and other pain relievers, Suzetrigine works differently by potentially providing pain relief without the risk of addiction. Researchers are excited about these treatments because Suzetrigine, when combined with Efavirenz, might offer a dual-action approach that targets pain more effectively. This combination could also minimize side effects typically associated with long-term pain medication use, offering a promising new option for patients seeking alternative pain relief.

What evidence suggests that Suzetrigine + Efavirenz could be effective for pain management?

Research has shown that suzetrigine effectively manages pain. In studies, 83.2% of patients reported good to excellent pain relief with suzetrigine. It has reduced moderate-to-severe pain, especially after surgeries like tummy tucks and foot surgeries. In this trial, participants will initially receive suzetrigine alone, followed by a combination of suzetrigine and efavirenz. When used as part of a combined treatment approach, about 90.7% of patients rated its effectiveness as excellent. These findings suggest suzetrigine could be a promising non-opioid option for pain relief.12467

Are You a Good Fit for This Trial?

This trial is for healthy adults (men and women who can't become pregnant) with a BMI between 18 and 32, weighing over 50 kg. People with certain health conditions or on medications that could affect the study are excluded.

Inclusion Criteria

Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2)
A total body weight of greater than (>) 50 kg
I am not able to have children.

Exclusion Criteria

History of any illness or any clinical condition that may confound the results of the study or pose an additional risk in administering study drug to the participant
I have not had a fever or acute illness in the last 5 days.
I have a condition that may affect how my body absorbs medicine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of Suzetrigine on Days 1 through 15, and a single dose of Suzetrigine in the morning followed by a single dose of efavirenz in the evening on Days 16 through 30

30 days

Safety Follow-up

Participants are monitored for safety and tolerability after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Efavirenz
  • Suzetrigine

Trial Overview

The study looks at how the body processes Suzetrigine alone and when taken together with Efavirenz. It also checks if taking both drugs together is safe for healthy participants.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: SUZ and EfavirenzExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vertex Pharmaceuticals Incorporated

Lead 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

Beyond Opioids: A Review of Suzetrigine for Acute Pain ...

A total of 83.2% of patients in the study felt that suzetrigine provided good or better pain relief. Notably, 91.2% of nonsurgical patients ...

Institute for Clinical and Economic Review Publishes Final ...

The majority of panelists (12-2) found that current evidence is not adequate to demonstrate a net health benefit of suzetrigine plus non- ...

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

A systematic review including multiple phase III trials demonstrated suzetrigine's efficacy for pain management in both non-surgical and post-surgical patients.

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 ...

Efficacy and Clinical Trials | JOURNAVX® (suzetrigine)

The primary endpoint in both trials was JOURNAVX superiority vs placebo on the time-weighted sum of the pain intensity difference (SPID) as recorded on the ...

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 ...

219209Orig1s000 - accessdata.fda.gov

the Safety and Effectiveness of Suzetrigine for Acute Pain (Study 107) provided uncontrolled safety data over a treatment period of up to 14 days. Study 107 ...