Suzetrigine (developmental code name VX-548) 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.[1][2] It is being developed by Vertex Pharmaceuticals and has completed two phase 3 clinical trials.[1][3]

Suzetrigine
Clinical data
Other namesVX-548
Legal status
Legal status
  • Investigational
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
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

Vertex Pharmaceuticals announced in January 2024 that suzetrigine successfully met several endpoints in its phase 3 trials. The drug relieved moderate-to-severe post-surgical pain. The company hopes that the drug, which operates on peripheral nerves, will avoid the addictive potential of opioids.[3][4]

Vertex Pharmaceuticals plans to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) by mid-2024 seeking a broad label for moderate-to-severe acute pain. Suzetrigine has already secured FDA Breakthrough Therapy and Fast Track designations for acute pain.[3]

Vertex Pharmaceuticals also plans to seek a broad label for peripheral neuropathic pain, citing positive phase 2 results in painful diabetic peripheral neuropathy (DPN).[3] The drug is additionally under development for the treatment of radiculopathy and pain in other contexts.[1]

See also

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References

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  1. ^ a b c "Suzetrigine - Vertex Pharmaceuticals". AdisInsight. 19 August 2024. Retrieved 24 August 2024.
  2. ^ Jones, Jim; Correll, Darin J.; Lechner, Sandra M.; Jazic, Ina; Miao, Xiaopeng; Shaw, David; Simard, Christopher; Osteen, Jeremiah D.; Hare, Brian; Beaton, Alina; Bertoch, Todd; Buvanendran, Asokumar; Habib, Ashraf S.; Pizzi, Lois J.; Pollak, Richard A.; Weiner, Scott G.; Bozic, Carmen; Negulescu, Paul; White, Paul F. (3 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. ISSN 1533-4406. PMID 37530822. S2CID 260377748.
  3. ^ a b c d Vertex Pharmaceuticals Incorporated Vertex Announces Positive Results From the VX-548 Phase 3 Program for the Treatment of Moderate-to-Severe Acute Pain. Press Release, Jan 30, 2024.
  4. ^ Kolata, Gina (30 January 2024). "Experimental Drug Cuts Off Pain at the Source, Company Says". The New York Times. Retrieved 31 January 2024.