Journavx
Pronunciation: jor na vix
Generic name: suzetrigine
Dosage form: tablet (50 mg)
What is Journavx?
Journavx (suzetrigine) is a new non-opioid pain-relieving tablet used to treat short-term (acute) moderate to severe pain. Journavx is a sodium channel blocker that relieves pain by blocking pain-sensing nerves around the body from transmitting pain messages to the spinal cord and brain. Since it does not affect the brain, is expected to have no addictive potential, unlike other pain treatments such as opioids.
Journavx's mechanism of action is by selectively blocking NaV1.8, a sodium channel on pain-sensing nerve cells (neurons), this inhibits pain signals going to the spinal cord and brain.
Journavx (suzetrigine) tablets are taken twice daily, every 12 hours after the first dose.
Journavx FDA approval was received on January 30, 2025, for treating moderate to severe acute pain in adults. This approval was based on positive results from Phase 3 clinical trials (VX21-548-101 and VX21-548-102), which showed that it effectively reduced acute pain for 48 hours after surgery.
How effective is Journavx?
In Phase 3 clinical trials, Journavx painkillers were more effective than a placebo in reducing pain and improving pain intensity for 48 hours after surgery (abdominoplasty and bunion removal). Pain levels were measured using the Numeric Pain Rating Scale (NPRS) and the Sum of Pain-Intensity Difference over 48 hours (SPID48). Higher SPID48 and NPRS values indicated greater pain relief. Results of clinical trials showed:
- Statistically and clinically meaningful improvements in pain intensity and pain reduction in baseline compared to placebo (an inactive pill).
- Abdominoplasty: Journavx 118.4 (LSM* SPID48) compared to 70.1 (LSM SPID48) placebo. The difference between Journavx and placebo was 48.4 (LSM SPID48)
- Bunion removal: Journavx 99.9 (LSM SPID48) compared to placebo 70.6 ((LSM SPID48). The difference between Journavx and placebo was 29.3 (LSM SPID48)
- The median time to meaningful pain relief was reported as 2 hours for abdominoplasty and 4 hours for bunion removal compared with 8 hours for placebo.
*LSM = Least squares mean
Journavx side effects
Journavx side effects include:
- Itching (2.1%)
- Muscle spasms (1.3%)
- Increased blood level of creatine phosphokinase (0.5%)
- Rash (0.5%)
The above side effects occurred in 1% or more Journavx patients in Trials 1 and 2 (pooled data).
Nausea and vomiting side effects
- Journavx treated patients (20% Trial 1, 9% Trial 2)
- Placebo-treated patients (25% Trial 1, 12% Trial 2)
Fertility
- This medicine may temporarily reduce the chance of females becoming pregnant while taking this medicine. Talk to your healthcare provider if you have concerns about becoming pregnant. If you are using contraceptives, you should continue to use contraceptives during treatment with Journavx.
- Hormonal birth control (contraceptives) containing progestins other than levonorgestrel or norethindrone may not work as well while taking Journavx.
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Related/similar drugs
Warnings
Liver impairment:
- These tablets should not be used if you have severe hepatic impairment ((Child-Pugh Class C).
- This medicine may increase the risk of side effects if you have moderate hepatic impairment (Child-Pugh Class B) compared to patients with normal liver function.
Strong inhibitors of CYP3A:
- Journavx should not be taken with medicines that are strong inhibitors of CYP3A due to a drug interaction. Ask your healthcare provider or prescriber to check if you are not sure.
Substrates of the CYP3A enzyme
- Medicines that are substrates of the CYP3A enzyme may become less effective during treatment with Journavx and your prescriber may need to adjust the dose of your medicine when starting or stopping Journavx.
Contraception:
- Hormonal birth control (contraceptives) containing progestins other than levonorgestrel or norethindrone may not work as well while taking Journavx. you should use an additional nonhormonal contraceptive method or an alternative hormonal contraceptive during concomitant use and for 28 days after Journavx discontinuation.
Before taking this medicine
Before taking this medicine tell your doctor or prescriber about all of your medical conditions, including if you:
- have liver problems. This medicine should not be used if you have severe liver impairment, or may cause side effects if you have moderate liver impairment. People with liver problems may have an increased risk of getting side effects from taking this medicine.
Pregnancy
Tell your healthcare provider if you are pregnant or plan to become pregnant as it is not known if this medicine will harm your unborn baby. You and your healthcare provider should decide if you will take these tablets while you are pregnant.
Hormonal birth control (contraceptives) containing progestins other than levonorgestrel or norethindrone may not work as well while taking Journavx. You should also use nonhormonal contraceptives such as condoms or other forms of hormonal birth control during treatment with this medicine and for 28 days after you stop taking Journavx.
Breastfeeding
Tell your healthcare provider if you are breastfeeding or planning to breastfeed as it is not known if Journavx passes into your breast milk. You and your healthcare provider should decide if you will take this medicine while you are breastfeeding.
How should I take Journavx?
- Swallow Journavx tablets whole, do not chew or crush the tablets.
- Your first dose is usually 100mg taken on an empty stomach (1 hour before food or 2 hours after food). You may drink clear liquids during this time such as water, vegetable broth, tea, black coffee, or apple juice.
- The usual maintenance dose is 12 hours after your starting dose, take 50 mg tablet every 12 hours, with or without food.
- Your dose may be modified if you have liver impairment or if you are on certain medications
- It is best to use this medicine for the shortest possible time.
Journavx Dose information
Usual initial dose: 100mg on an empty stomach (1 hour before food or 2 hours after food).
Usual maintenance dose: 50mg every 12 hours, starting 12 hours after the initial dose.
Dose modification: according to liver impairment or medication interactions.
Journavx is available as: 50mg tablet.
What happens if I miss a dose?
If you miss a dose of Journavx and you:
- do not have liver problems or take certain other medicines:
- Take the missed dose as soon as possible, then take your next scheduled dose at your recommended time.
- If you miss 2 or more doses of Journavx, take 2 tablets, then take your next scheduled dose at your recommended time.
- have liver problems or are taking moderate inhibitors of an enzyme called CYP3A:
- Take the missed dose as soon as possible.
- If you took the missed dose and your next scheduled dose is within 6 hours, skip that dose and take your next scheduled dose at your recommended time.
If you are not sure about your dosing, check with your healthcare provider or pharmacist.
What happens if I overdose?
If you take too much of this medicine, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
What should I avoid while taking this medicine?
Avoid consuming food or drinks that contain grapefruit.
What other drugs will affect Journavx?
Tell your healthcare provider or prescriber about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Journavx with other medicines may affect how this medicine works and the way other medicines work, and may also increase your risk of side effects.
Strong and Moderate CYP3A inhibitors:
- Using Journavx with strong CYP3A inhibitors is contraindicated.
- Reduce the Journavx dose when used concomitantly with moderate CYP3A inhibitors.
- Avoid food or drink containing grapefruit.
Strong and Moderate CYP3A inducers:
- Avoid using this medicine with strong or moderate CYP3A inducers.
CYP3A substrates:
- If Journavx is used together with sensitive CYP3A substrates or CYP3A substrates where minimal concentration changes may lead to loss of efficacy, then you should refer to the Prescribing Information for the CYP3A substrates for dosing instructions. Dosage modification of the concomitant CYP3A substrates may be required when initiating or discontinuing Journavx.
Hormonal contraceptives: If you are taking Journavx while using hormonal contraceptives containing progestins other than levonorgestrel and norethindrone you should use an additional nonhormonal contraceptive method or an alternative hormonal contraceptive during concomitant use and for 28 days after Journavx discontinuation.
This list may not be complete and other medicines may result in drug interactions.
Storage
Store at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
Ingredients
Active ingredient: suzetrigine
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.
Company
Journavx: Vertex Pharmaceuticals Incorporated; 50 Northern Avenue, Boston, MA 02210.
References
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
