Suzetrigine for Lactation Safety
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how suzetrigine and its active ingredient are processed in the breast milk of breastfeeding mothers. Researchers aim to determine how much of the drug passes into breast milk and assess its safety for both mothers and their babies. Suitable participants include women who have been breastfeeding or pumping regularly, at least three times a day, and are 6 weeks to 12 months postpartum. Participants will receive a single dose of the medication and must maintain their milk supply by continuing to pump. The study aims to ensure the medication's safety during lactation. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking safety research.
Is there any evidence suggesting that suzetrigine is likely to be safe for humans?
Research has shown that suzetrigine has been tested for safety in over 1,000 patients in various situations. These studies found it to be generally well-tolerated. However, specific information about its safety for breastfeeding mothers is not yet available. Suzetrigine binds strongly to proteins in the blood, which might reduce its passage into breast milk.
While direct evidence on suzetrigine's effects on breastfed babies is lacking, its extensive testing in other areas offers some reassurance about its safety. Prospective participants should consult their healthcare provider with any concerns or questions before joining a trial.12345Why do researchers think this study treatment might be promising?
Unlike other treatments for lactation safety, Suzetrigine offers a novel approach because it focuses on ensuring the safety of medication use during breastfeeding without compromising the health of the infant. Current options often involve either avoiding certain medications or using those with a well-established safety profile, but Suzetrigine is being explored for its potential to expand safe medication choices for breastfeeding mothers. Researchers are particularly excited about its unique active ingredient, which aims to minimize any adverse effects on both mothers and their babies while maintaining therapeutic efficacy. This could significantly broaden the range of safe medications available for breastfeeding women, offering them more flexibility in managing their health.
What evidence suggests that suzetrigine might be an effective treatment for lactation safety?
Studies have shown that suzetrigine effectively treats sudden pain by blocking pathways that transmit pain signals in the body. Research from two trials confirmed it reduces pain with fewer side effects, such as nausea and dizziness, compared to opioids. However, specific information on suzetrigine's effects on breastfeeding mothers or their babies remains unavailable. In this trial, participants will receive a single dose of suzetrigine to determine its presence in breast milk and its safety for nursing mothers.12467
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of suzetrigine (SUZ) on Day 1
Follow-up
Participants are monitored for safety, tolerability, and pharmacokinetics of SUZ and its active metabolite
What Are the Treatments Tested in This Trial?
Interventions
- Suzetrigine
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive a single dose of SUZ on Day 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vertex Pharmaceuticals Incorporated
Lead Sponsor
Dr. David Altshuler
Vertex Pharmaceuticals Incorporated
Chief Medical Officer since 2020
MD, PhD
Dr. Reshma Kewalramani
Vertex Pharmaceuticals Incorporated
Chief Executive Officer since 2020
MD, trained in internal medicine and nephrology
Citations
Suzetrigine - Drugs and Lactation Database (LactMed®) - NCBI
No information is available on the clinical use of suzetrigine during breastfeeding. Because suzetrigine is more than 99% bound to plasma ...
Evaluation of the Excretion of Suzetrigine Into Breast Milk ...
The study is being conducted to evaluate the PK, safety and tolerability of SUZ and its active metabolite in lactating female participants. This clinical trial ...
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 ...
Suzetrigine (Journavx) use while Breastfeeding
Advice for mothers using Suzetrigine (Journavx) while breastfeeding. Includes possible effects on breastfed infants and lactation.
Clinical Efficacy and Safety Profile of Suzetrigine: A Novel Non ...
The drug displayed a favorable safety profile with a lower incidence of common opioid-related adverse effects, such as nausea and dizziness, and ...
Important Safety Information | JOURNAVX® (suzetrigine)
JOURNAVX may temporarily reduce the chance of females becoming pregnant while on treatment; are breastfeeding or planning to breastfeed. Tell your healthcare ...
JOURNAVX (suzetrigine) tablets, for oral use.
Risk Summary. There are no data on the presence of suzetrigine or its metabolites in human milk, the effects on the breastfed infant, or the.
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