Brand Name
Journavx
Generic Name
Suzetrigine
View Brand Information FDA approval date: January 30, 2025
Classification: Sodium Channel Blocker
Form: Tablet
What is Journavx (Suzetrigine)?
JOURNAVX is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. JOURNAVX is a sodium channel blocker indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults.
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Related Clinical Trials
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
Summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine in participants with pain associated with diabetic peripheral neuropathy (DPN).
A Phase 3, Randomized, Double-blind, Placebo- and Active-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
Summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).
A Randomized, Placebo-controlled, Double-blind Trial of Suzetrigine in Total Hip Arthroplasty
Summary: Total hip and knee joint replacements are among the most common and painful orthopedic procedures performed worldwide, often requiring intensive analgesia to support early ambulation and recovery. Despite widespread use of multimodal regimens, many patients still rely on opioids, which can cause sedation, nausea, constipation, and long-term dependency. Evaluating Suzetrigine in this high-need popu...
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Brand Information
JOURNAVX (Suzetrigine)
1INDICATIONS AND USAGE
JOURNAVX is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults.
2DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg, blue, film-coated, oblong tablets debossed with "VX50" on one side and plain on the other.
3CONTRAINDICATIONS
Concomitant use of JOURNAVX with strong CYP3A inhibitors is contraindicated
4OVERDOSAGE
No specific antidote is available for overdose with JOURNAVX. Treatment of overdose consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
5DESCRIPTION
The active ingredient in JOURNAVX (suzetrigine) tablets is suzetrigine, a sodium channel blocker, which has the following chemical name:
- 4-[(2
Suzetrigine's molecular weight is 473.39 g/mol. Suzetrigine has the following structural formula:
Suzetrigine is a white to off-white solid and is practically insoluble in water.
JOURNAVX is available as a blue, film-coated tablet for oral administration containing 50 mg of suzetrigine and the following inactive ingredients: croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, and microcrystalline cellulose. The tablet film coat contains FD&C Blue #2 aluminum lake, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.
6HOW SUPPLIED/STORAGE AND HANDLING
JOURNAVX (suzetrigine) tablets are supplied as blue, film-coated, oblong tablets containing 50 mg of suzetrigine. Each tablet is debossed with the characters "VX50" on one side and plain on the other, and is packaged as follows:
- 30-count bottle NDC 51167-548-30
- 100-count bottle NDC 51167-548-31
- 100-count Hospital Unit Dose Carton (10 blister cards, each containing 10 tablets) NDC 51167-548-34
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
8PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label
Rx Only
NDC 51167-548-30
JOURNAVX™
50 mg
Contains: 30 tablets
Recommended Dosage:
9PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label - NDC 51167-548-31
Rx Only
NDC 51167-548-31
JOURNAVX™
50 mg
Contains: 100 tablets
Recommended Dosage:
10PRINCIPAL DISPLAY PANEL - 50 mg Tablet Blister Pack Carton
For institutional use only
NDC 51167-548-34
JOURNAVX™
50 mg
100 tablets
UNIT DOSE
11PRINCIPAL DISPLAY PANEL - 50 mg Tablet Blister Pack Carton - Professional Sample
PROFESSIONAL SAMPLE - NOT FOR SALE
NDC 51167-548-25
JOURNAVX™
50 mg per tablet
For Oral Use
Contains:
