Suzetrigine for Pain

MI
Overseen ByMedical Information
Age: 18+
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 examines how a new treatment, Suzetrigine (SUZ) Spray-dried Dispersion (SSD), affects taste and texture sensations in the mouth. The goal is to understand how different doses alter these sensory experiences. Participants will hold the treatment in their mouths briefly before spitting it out. The trial seeks individuals skilled in detecting and describing flavors, so those with experience in taste testing or flavor identification might be a good fit. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the chance to be among the first to experience it.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for more details.

Is there any evidence suggesting that Suzetrigine is likely to be safe for humans?

Research shows that Suzetrigine (SUZ) Spray-dried Dispersion (SSD) remains in the early testing stages, so limited safety information is available. However, SUZ has undergone testing before.

Early studies generally focus on safety and identifying side effects, and this applies to SUZ as well. Although detailed results are not yet available, early trials typically use small doses to minimize the risk of serious side effects.

Additionally, safety guidelines advise against inhaling SUZ or allowing contact with eyes or skin, as it might cause irritation. This does not imply the treatment is unsafe when used correctly in the study.

Overall, while specific data is not yet available, the emphasis on safety in early trials suggests that serious side effects are not expected. Participants should discuss any concerns with the study team before deciding to join.12345

Why do researchers think this study treatment might be promising?

Suzetrigine (SUZ) is unique because it offers a new delivery method for managing pain. Unlike traditional pain medications that are often taken orally or injected, SUZ is a spray-dried dispersion that participants hold in their mouths for about 10 seconds before spitting it out. This innovative approach could potentially provide faster relief with fewer systemic side effects, making it a promising option for those who struggle with conventional pain treatments. Researchers are excited about the potential of SUZ to offer a more targeted and convenient way to manage pain.

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

Research has shown that Suzetrigine (SUZ) effectively reduces pain. One study found it lowered pain levels in people with moderate to severe pain. As a non-opioid treatment, Suzetrigine is not addictive. It targets a specific protein involved in sending pain signals, thereby blocking pain. This makes it a promising option for managing sudden pain without the risks associated with opioids.14678

Are You a Good Fit for This Trial?

This trial is for healthy adults who are trained and experienced in detecting, identifying, recognizing, and accurately describing different taste elements and flavor combinations. Specific qualifications based on sensory analysis skills are required.

Inclusion Criteria

I am trained and experienced in accurately identifying tastes and flavors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive SUZ SDD to evaluate sensory attributes

1 day
1 visit (in-person)

Follow-up

Participants are monitored for any immediate reactions after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Suzetrigine (SUZ) Spray-dried Dispersion (SSD)
Trial Overview The study is testing the sensory attributes of Suzetrigine (SUZ) Spray-dried Dispersion (SSD), focusing on its basic tastes, aroma, texture, mouthfeel, and how these may change with different doses.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: SUZExperimental Treatment1 Intervention

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

NCT06834009 | A Study of Suzetrigine (SUZ) Spray-dried ...The purpose of this study is to evaluate the sensory attributes (basic tastes, aroma, texture, mouthfeel) of SUZ SDD and assess the impact of the dose on the ...
Suzetrigine for Acute Pain:Effectiveness and ValueWe aimed to assess the clinical effectiveness and safety of suzetrigine as an add-on to non-systemic treatments for patients with moderate to ...
Suzetrigine | MedRAC@UNCThe approval was based on data from a phase 3 clinical trial that showed that Suzetrigine was effective in reducing pain intensity in patients with moderate to ...
Suzetrigine, a Non-Opioid NaV1.8 Inhibitor With Broad ...Suzetrigine provides a safe and effective non-opioid, non-addictive treatment with broad applicability for moderate-to-severe acute pain.
Vertex Announces Results From Phase 2 Study of ...The study met its primary endpoint with statistically significant and clinically meaningful reduction in pain on the numeric pain rating scale (NPRS).
Safety Data SheetFor disposal see section 13. 7. HANDLING AND STORAGE. 7.1 Precautions for safe handling. Avoid inhalation, contact with eyes and skin. Avoid ...
A Study of Suzetrigine (SUZ) Spray-dried Dispersion (SSD) ...The purpose of this study is to evaluate the sensory attributes (basic tastes, aroma, texture, mouthfeel) of SUZ SDD and assess the impact of the dose on the ...
Safety Data SheetAvoid breathing dust/fume/gas/mist/vapours/spray. Avoid prolonged or repeated exposure. Keep away from sources of ignition. Take precautionary ...
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