JOURNAVX® (suzetrigine)

The First Non-Opioid Oral Pain Signal Inhibitor for Moderate-to-Severe Acute Pain in Adults

Facts and Information about JOURNAVX

Acute pain is short-term pain that typically follows surgery, an accident, or injury. It is one of the most common reasons adults seek medical care — and until recently, treating it often meant choosing between inadequate relief or opioid medications that carry real addiction risk.

JOURNAVX (suzetrigine) is a prescription medicine used to treat adults with moderate-to-severe short-term (acute) pain, including postoperative pain. It is the first non-opioid oral pain signal inhibitor and the first entirely new class of pain medicine approved in more than 20 years.

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JOURNAVX may help adults with the following:

Post-surgical acute pain. Pain following orthopedic procedures, soft tissue surgeries, and a wide range of other operations where moderate-to-severe acute pain is expected.
Injury-related acute pain. Moderate-to-severe pain resulting from trauma, accidents, or musculoskeletal injuries.
Other acute pain conditions. JOURNAVX has been studied across a variety of surgical and non-surgical acute pain settings with a consistently favorable safety profile.

How Does JOURNAVX Work?

Pain signals begin in your peripheral nervous system — the network of nerves located outside your brain and spinal cord. A specific protein called NaV1.8 plays a central role in carrying those signals toward the brain.

JOURNAVX works by selectively blocking the NaV1.8 sodium channel, reducing pain signals at their source — before they can travel to your brain. This is why JOURNAVX is described as a "pain signal inhibitor."

Why Does This Matter?

Because JOURNAVX acts in the peripheral nervous system rather than the brain, it does not carry the risks associated with opioids. It does not cause sedation or respiratory depression, and clinical studies show no evidence of addictive potential.

How Is JOURNAVX Different from Opioids?

Opioids work by binding to receptors in the brain — which is why they cause sedation and carry addiction risk. JOURNAVX intercepts pain before it reaches the brain, offering effective relief through a completely different pathway. It is the first drug in this entirely new class of pain medicines, and the first new oral non-opioid pain treatment approved in over 20 years.

How Is JOURNAVX Taken?

JOURNAVX is an oral tablet prescribed by your doctor. It is swallowed whole — do not chew or crush. Always follow the dosing instructions exactly as directed on your prescription label.

Starting Dose	100 mg taken on an empty stomach at least 1 hour before or 2 hours after food. Clear liquids such as water, apple juice, tea, or black coffee are permitted.
Ongoing Doses	Starting 12 hours after the first dose: 50 mg every 12 hours. These doses may be taken with or without food.
How to Take	Swallow tablets whole. Do not chew or crush. Avoid grapefruit and grapefruit juice during treatment.
Duration	Use for the shortest time needed to meet your treatment goals. Use beyond 14 days has not been studied.
Missed Dose	Take as soon as you remember, then continue your regular schedule. Do not take two doses at once.

Dosing schedule and treatment duration will be directed by your prescribing physician. Talk to your doctor or pharmacist if you have questions.

What Are the Expected Results?

The FDA approved JOURNAVX based on two randomized, double-blind, placebo- and active-controlled Phase 3 clinical trials — NAVIGATE 1 and NAVIGATE 2 — involving over 2,100 adults with moderate-to-severe acute surgical pain.

NAVIGATE 2 (Bunionectomy Trial)

Patients experienced perceptible pain relief within a median of 60 minutes after the first dose. Meaningful pain relief — defined as at least a 2-point reduction on the numeric pain rating scale — was achieved at a median of 240 minutes, compared to 480 minutes for placebo.

NAVIGATE 1 (Abdominoplasty Trial)

JOURNAVX delivered statistically significant pain reduction compared to placebo across both 48-hour primary endpoints. Meaningful pain relief was achieved in a median of 119 minutes.

Phase 3 Safety and Effectiveness Study

In a separate open-label study across a variety of acute pain conditions, 83% of patients rated JOURNAVX as good, very good, or excellent at treating their pain. No serious adverse events were reported.

83%

of patients rated JOURNAVX good, very good, or excellent at treating pain

60 min

median time to onset of perceptible pain relief (bunionectomy trial)

2,100+

adults studied in Phase 3 clinical trials across multiple acute pain conditions

Is There a Longer-Lasting Treatment?

JOURNAVX is currently approved for moderate-to-severe acute (short-term) pain. Vertex Pharmaceuticals is actively studying suzetrigine for chronic pain conditions, including painful diabetic peripheral neuropathy and lumbosacral radiculopathy. Ask your doctor about options if your pain persists beyond the acute period.

Safety Information

As with any prescription medicine, it is important to understand both when JOURNAVX can help and what precautions apply. Review this information carefully with your doctor or pharmacist.

Do Not Take JOURNAVX If You:

Take strong CYP3A inhibitor medicines (ask your doctor if you're unsure)
Have severe liver (hepatic) impairment

Tell Your Doctor If You:

Have liver problems
Are pregnant, plan to become pregnant, or are breastfeeding
Take hormonal birth control with progestins other than levonorgestrel or norethindrone
Take any prescription or over-the-counter medicines, vitamins, or supplements

Common Side Effects Include:

Itching (pruritus)
Muscle spasms
Rash
Increased blood levels of creatine phosphokinase

Avoid During Treatment:

Grapefruit or grapefruit juice
Strong CYP3A inhibitor medications
Using beyond 14 days without physician guidance

These are not all possible side effects or precautions. Call your healthcare provider for advice. Report side effects to the FDA at 1-800-FDA-1088.

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Important Safety Information

INDICATION: JOURNAVX® (suzetrigine) is a prescription medicine used to treat adults with moderate-to-severe short-term (acute) pain, including postoperative pain. It is not known if JOURNAVX is safe and effective in children.

Contraindication

Do not take JOURNAVX if you take certain medicines that are strong inhibitors of CYP3A. Ask your healthcare provider if you are unsure.

Before Taking JOURNAVX, Tell Your Doctor If You:

Have liver problems — people with liver problems may have an increased risk of side effects
Are pregnant or plan to become pregnant — JOURNAVX may temporarily reduce the chance of becoming pregnant while on treatment
Are breastfeeding or plan to breastfeed
Take hormonal birth control containing progestins other than levonorgestrel or norethindrone, as they may not work as well during treatment
Take any other prescription or over-the-counter medicines, vitamins, or herbal supplements

Common Side Effects

The most common adverse reactions (≥1% of patients) were: itching (pruritus), muscle spasms, increased blood creatine phosphokinase, and rash.

Additional Precautions

Avoid food or drink containing grapefruit during treatment
Use JOURNAVX for the shortest duration consistent with your treatment goals
Use beyond 14 days has not been studied

These are not all possible side effects. Call your healthcare provider for medical advice. You may report side effects to the FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Patient Information, for JOURNAVX at journavx.com.

JOURNAVX® is a registered trademark of Vertex Pharmaceuticals Incorporated. This page is for informational purposes only and is not a substitute for the advice of your healthcare provider.