New nonopioid approved for moderate-to-severe acute pain

(BPT) - Acute pain can affect anyone.¹ Short-term pain (acute) starts suddenly following an injury or medical procedure and lasts less than three months.^2,3 Acute pain can impact your quality of life, disrupt your day, and can affect your professional and emotional well-being.^4,5 Forming a treatment plan with your doctor to help manage your acute pain is important, as inadequate pain management can have consequences that affect a patient's quality of life.⁴

There are approximately 80 million U.S. adults prescribed acute pain medication annually, and about 40 million receive opioids to manage their pain.⁶ While opioids can be effective, they also carry a risk of addiction.⁷ In fact, each year, Vertex Pharmaceuticals estimates approximately 85,000 patients develop opioid use disorder (OUD) within one year of starting an opioid treatment.⁸

Health care providers may prescribe either acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs) as alternatives.⁷ While these treatments are generally well tolerated, they may have limited effectiveness, particularly for moderate-to-severe acute pain.⁷

A new path to pain management

Today, adult patients have a new option to treat their moderate-to-severe acute pain. As of January 2025, the Food and Drug Administration (FDA) approved JOURNAVX™ (suzetrigine), the first new class of medicine for acute pain in more than 20 years.^9-12

JOURNAVX is an oral, nonopioid, selective Na_V1.8 pain signal inhibitor approved for the treatment of moderate-to-severe acute pain in adults.^9,13 JOURNAVX reduces pain by targeting a specific sodium channel in the peripheral nervous system that blocks pain signals prior to reaching the brain.^9,13 Opioid medications can act on both the peripheral nervous system and the central nervous system (CNS). Acting on the CNS triggers the brain reward system, which may lead to opioid misuse, addiction and opioid use disorder.^14-17

JOURNAVX is a prescription medicine used to treat adults with moderate-to-severe short-term (acute) pain.⁹ It is widely available and is now on the shelves in retail pharmacies across the country. For more information about JOURNAVX, visit JOURNAVX.com or speak with your doctor.

This article was sponsored by Vertex Pharmaceuticals Incorporated.

INDICATION AND USAGE

JOURNAVX is a prescription medicine used to treat adults with moderate-to-severe short-term (acute) pain.

It is not known if JOURNAVX is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Patients should not take JOURNAVX if they take certain medicines that are strong inhibitors of an enzyme called CYP3A. Patients should ask their healthcare providers if they are not sure.

Before taking JOURNAVX, patients should tell their healthcare provider about all of their medical conditions, including if they: have liver problems, as people with liver problems may have an increased risk of getting side effects from taking JOURNAVX; are pregnant or plan to become pregnant, as it is not known if JOURNAVX will harm an unborn baby. Patients and their healthcare providers should decide if they will take JOURNAVX while they are pregnant, are breastfeeding, or are planning to breastfeed, as it is not known if JOURNAVX passes into breast milk. Patients and their healthcare providers should decide if they will take JOURNAVX while they are breastfeeding.

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking JOURNAVX with certain other medicines may affect the way JOURNAVX and the other medicines work and may increase patients' risk of side effects. Patients should ask their healthcare provider or pharmacist for a list of these medicines if they are not sure.

Patients should especially tell their healthcare provider if they take hormonal birth control medicine (contraceptives) containing progestins other than levonorgestrel or norethindrone. If they take one of these contraceptives (progestins other than levonorgestrel or norethindrone), they may not work as well during treatment with JOURNAVX. Patients should also use nonhormonal contraceptives such as condoms or use other forms of hormonal birth control during treatment with JOURNAVX and for 28 days after they stop taking JOURNAVX. Medicines that are substrates of the CYP3A enzyme may become less effective during treatment with JOURNAVX. Their healthcare provider may need to adjust the dose of patients' medicine when starting or stopping JOURNAVX. Patients should know the medicines they take and keep a list of them to show their healthcare provider and pharmacist when they get a new medicine. Patients should not take food or drink containing grapefruit while taking JOURNAVX.

JOURNAVX can cause side effects: The most common side effects for patients treated with JOURNAVX include itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. JOURNAVX may temporarily reduce the chance of females becoming pregnant while on treatment. Patients should talk to their healthcare provider if they have concerns about becoming pregnant. If patients are using contraceptives, continue to use contraceptives during treatment with JOURNAVX. Patients should tell their healthcare provider if they have any side effect that bothers them or that does not go away. These are not all of the possible side effects of JOURNAVX. Patients should call their healthcare provider for medical advice about side effects. Patients may report side effects to the FDA at 1-800-FDA-1088.

Please click here for the full Prescribing Information, including Patient Information, for JOURNAVX.

JOURNAVX is manufactured for Vertex Pharmaceuticals Incorporated.

JOURNAVX is a trademark of Vertex Pharmaceuticals Incorporated.

© 2025 Vertex Pharmaceuticals Incorporated | VXR-US-43-2500326 (v1.0) | 04/2025

1. "Ouch, that hurts!" The science of pain. NIH MedlinePlus Magazine. Accessed February 20, 2025. https://magazine.medlineplus.gov/article/ouch-that-hurts-the-science-of-pain.
2. Pain management center. International Association for the Study of Pain (IASP). Accessed February 20, 2025. https://www.iasp-pain.org/resources/toolkits/pain-management-center/chapter1/.
3. Acute pain. International Association for the Study of Pain (IASP). January 12, 2023. Accessed February 20, 2025. https://www.iasp-pain.org/resources/topics/acute-pain/.
4. Sinatra R. Causes and consequences of inadequate management of acute pain. Pain Med. 2010;11(12):1859-1871. doi:10.1111/j.1526-4637.2010.00983.x.
5. Strassels S, McNichol E, Wagner A, et al. Persistent postoperative pain, health-related quality of life, and functioning 1 month after hospital discharge. Acute Pain. 2004;6(3-4): 95-104. doi:10.1016/j.acpain.2004.08.002.
6. Lopez A, Jones J, Menzie AM, Peta S, Ippolito A, Rubin J. An evaluation of the prevalence of acute and chronic pain medication use in the United States: a real-world database analysis. Presented at: ASRA Annual Pain Medicine Meeting; November 10-11, 2023; New Orleans, LA.
7. Blondell RD, Azadfard M, Wisniewski AM. Pharmacologic therapy for acute pain. Am Fam Physician. 2013;87(11):766-772.
8. Data on file. Vertex Pharmaceuticals Incorporated. Boston, MA. REF-25086 (v1.0); 2024.
9. JOURNAVX [prescribing information]. Vertex Pharmaceuticals Incorporated. Boston, MA; January 2025.
10. Conaghan PG. A turbulent decade for NSAIDs: update on current concepts of classification, epidemiology, comparative efficacy, and toxicity. Rheumatol Int. 2012;32(6):1491-1502. doi:10.1007/s00296-011-2263-6.
11. Drug Therapeutics & Regulation in the U.S. U.S. Food & Drug Administration. January 31, 2023. Accessed February 20, 2025. https://www.fda.gov/about-fda/fda-history-exhibits/drug-therapeutics-regulation-us.
12. Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention. January 13, 2025. Accessed February 20, 2025. https://www.fda.gov/drugs/food-and-drug-administration-overdose-prevention-framework/timeline-selected-fda-activities-and-significant-events-addressing-substance-use-and-overdose.
13. Osteen JD, Immani S, Tapley TL, et al. Pharmacology and mechanism of action of suzetrigine, a potent and selective NaV1.8 pain signal inhibitor for the treatment of moderate to severe pain. Pain Ther. doi:10.1007/s40122-024-00697-0.
14. Oesterle TS. What are opioids and why are they dangerous? Mayo Clinic. August 26, 2023. Accessed March 25, 2025. https://www.mayoclinic.org/diseases-conditions/prescription-drug-abuse/expert-answers/what-are-opioids/faq-20381270.
15. Amaechi O, Huffman MM, Featherstone K. Pharmacologic therapy for acute pain. Am Fam Physician. 2021;104(1):63-72.
16. How opioid use disorder occurs. Mayo Clinic. July 20, 2024. Accessed December 10, 2024. https://www.mayoclinic.org/diseases-conditions/prescription-drug-abuse/in-depth/how-opioid-addiction-occurs/art-20360372.
17. Sehgal N, Smith HS, Manchikanti L. Peripherally acting opioids and clinical implications for pain control. Pain Physician. 2011;14(3):249-258.

© 2025 Vertex Pharmaceuticals Incorporated | VXR-US-43-2500326 (v1.0) | 04/2025