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Suzetrigine

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Suzetrigine
Clinical data
Pronunciation/suːˈzɛtrɪdʒiːn/
soo-ZE-tri-jeen
Trade namesJournavx
Other namesVX-548
License data
Routes of
administration		By mouth
Drug classNav1.8 sodium channel blocker; Analgesic
ATC code
  • None
Legal status
Legal status
Identifiers
  • 4-[[(2R,3S,4S,5R)-3-(3,4-Difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)oxolane-2-carbonyl]amino]pyridine-2-carboxamide
CAS Number
PubChem CID
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC21H20F5N3O4
Molar mass473.400 g·mol−1
3D model (JSmol)
  • CC1C(C(OC1(C)C(F)(F)F)C(=O)NC2=CC(=NC=C2)C(=O)N)C3=C(C(=C(C=C3)F)F)OC
  • InChI=1S/C21H20F5N3O4/c1-9-14(11-4-5-12(22)15(23)16(11)32-3)17(33-20(9,2)21(24,25)26)19(31)29-10-6-7-28-13(8-10)18(27)30/h4-9,14,17H,1-3H3,(H2,27,30)(H,28,29,31)/t9-,14-,17-,20-/m0/s1
  • Key:XSQUJFKRXZMOKA-PAFIKIDNSA-N

Suzetrigine, sold under the brand name Journavx, is a medication used for the management of pain.[1][2] It is a non-opioid, small-molecule analgesic that works as a selective inhibitor of Nav1.8-dependent pain-signaling pathways in the peripheral nervous system,[3][4] avoiding the addictive potential of opioids. Suzetrigine is taken by mouth.[1]

The most common adverse reactions include itching, muscle spasms, increased blood level of creatine kinase, and rash.[1][2]

It was developed by Vertex Pharmaceuticals,[5] and was approved for medical use in the United States in January 2025.[2][6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines.[2]

Medical uses

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Suzetrigine is indicated for the treatment of moderate to severe acute pain in adults.[1][2]

Effectiveness

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When people used suzetrigine in clinical studies conducted through 2024, there was a reduction in pain typically from seven to four on the standard numerical scale used to rate pain.[7][8] Suzetrigine provided pain relief equal to a combination of hydrocodone and acetaminophen.[8][9]

Suzetrigine suppresses pain at the same level as an opioid, but without the risks of addiction, sedation or overdose.[10] An alternative to opioids, it is the first pain medication to be approved by the Food and Drug Administration in two decades.[10]

The efficacy of suzetrigine was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy.[2] Both trials found that suzetrigine reduced pain more effectively than a placebo.[2]

Contraindications

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Concomitant use of suzetrigine with strong CYP3A inhibitors is contraindicated.[1][2]

Adverse effects

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Common adverse effects of suzetrigine may include itching, rash, muscle spasms, and increased levels of creatine kinase.[2] Mild side effects may include nausea, constipation, headache, and dizziness.[7][8] As of 2024, long-term safety and side effects remain undetermined.[8]

In preliminary research, suzetrigine had no serious neurological, behavioral, or cardiovascular effects.[3]

Interactions

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Consuming grapefruit while using suzetrigine may cause an adverse grapefruit–drug interaction.[1][2]

Mechanism of action

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Suzetrigine operates on peripheral nerves, avoiding the addictive potential of opioids which affect the central nervous system.[3][4][7] Unlike opioid medications, which reduce pain signals in the brain, suzetrigine works by closing sodium channels in peripheral nerves, inhibiting pain-signaling nerves from transmitting painful sensations to the brain.[3][4][7]

In pharmacological studies, suzetrigine selectively inhibited Nav1.8 channels, but not other voltage-gated sodium channels, and bound to a unique site on these sodium channels with a novel allosteric mechanism.[3]

History

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Vertex Pharmaceuticals announced in January 2024 that suzetrigine had successfully met several endpoints in its phase III clinical trials.[5] The company announced in July 2024 that the US Food and Drug Administration (FDA) had accepted a new drug application for suzetrigine.[11] The FDA granted the application for suzetrigine priority review, fast track, and breakthrough therapy designations for the treatment of moderate-to-severe acute pain.[11]

Society and culture

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Suzetrigine was approved for medical use in the United States in January 2025.[2]

Names

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Suzetrigine is the international nonproprietary name.[12]

Suzetrigine is sold under the brand name Journavx.[1][2]

References

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  1. ^ a b c d e f g h "Journavx (suzetrigine) tablets, for oral use: HIGHLIGHTS OF PRESCRIBING INFORMATION" (PDF). Vertex Pharmaceuticals. January 2025.
  2. ^ a b c d e f g h i j k l "FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain" (Press release). U.S. Food and Drug Administration (FDA). 30 January 2025. Retrieved 30 January 2025. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ a b c d e Osteen, Jeremiah D.; Immani, Swapna; Tapley, Tim L.; Indersmitten, Tim; Hurst, Nicole W.; Healey, Tiffany; et al. (January 2025). "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 and Therapy. doi:10.1007/s40122-024-00697-0. PMID 39775738.
  4. ^ a b c Jones, Jim; Correll, Darin J.; Lechner, Sandra M; Jazic, Ina; Miao, Xiaopeng; Shaw, David; et al. (August 2023). "Selective Inhibition of NaV1.8 with VX-548 for Acute Pain". The New England Journal of Medicine. 389 (5): 393–405. doi:10.1056/NEJMoa2209870. PMID 37530822. S2CID 260377748.
  5. ^ a b "Vertex Announces Positive Results From the VX-548 Phase 3 Program for the Treatment of Moderate-to-Severe Acute Pain" (Press release). Vertex. 30 January 2024. Retrieved 31 January 2025 – via Business Wire.
  6. ^ Constantino, Annika Kim (30 January 2025). "FDA approves Vertex's non-opioid painkiller, first new kind of pain medicine in decades". CNBC. Retrieved 30 January 2025.
  7. ^ a b c d Broadfoot, Marla (20 August 2024). "New Painkiller Could Bring Relief to Millions — Without Addiction Risk". Scientific American. Retrieved 31 January 2025.
  8. ^ a b c d Hang Kong, Aaron Yik; Tan, Hon Sen; Habib, Ashraf S. (September 2024). "VX-548 in the treatment of acute pain". Pain Management. 14 (9): 477–486. doi:10.1080/17581869.2024.2421749. PMID 39552600.
  9. ^ Kingwell, Katie (December 2024). "NaV1.8 inhibitor poised to provide opioid-free pain relief". Nature Reviews. Drug Discovery. 24 (1): 3–5. doi:10.1038/d41573-024-00203-3. PMID 39668193.
  10. ^ a b Dolgin, Elie (31 January 2025). "US drug agency approves potent painkiller — the first non-opioid in decades". Nature. doi:10.1038/d41586-025-00274-1. ISSN 1476-4687.
  11. ^ a b "Vertex Announces FDA Acceptance of New Drug Application for Suzetrigine for the Treatment of Moderate-to-Severe Acute Pain" (Press release). Vertex. 30 July 2024. Retrieved 31 January 2025 – via Business Wire.
  12. ^ World Health Organization (2023). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 90". WHO Drug Information. 37 (3). hdl:10665/373341.

Further reading

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  • Oliver, Brian; Devitt, Catherine; Park, Grace; Razak, Alina; Liu, Sun Mei; Bergese, Sergio D. (2025). "Drugs in Development to Manage Acute Pain". Drugs. 85 (1): 11–19. doi:10.1007/s40265-024-02118-0. PMID 39560856.
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