Suzetrigine

Suzetrigine
Clinical data
Other namesVX-548
Legal status
Legal status
  • Investigational
Identifiers
IUPAC name
  • 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
Chemical and physical data
FormulaC21H20F5N3O4
Molar mass473.400 g·mol−1

Suzetrigine (VX-548) is a non-opioid, small-molecule analgesic that works as a selective inhibitor of Nav1.8-dependant pain signaling pathways in the peripheral nervous system.[1] It is being developed by Vertex Pharmaceuticals and has completed two Phase III trials.[2]

Vertex announced in January 2024 that VX-548 successfully met several endpoints in its Phase III trials. The drug relieved moderate to severe post-surgical pain. Vertex hopes the drug, which operates on peripheral nerves, will avoid the addictive potential of opioids.[2][3]

Vertex 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. VX-548 has already secured FDA Breakthrough Therapy and Fast Track designations for acute pain.[2]

Vertex also plans to seek a broad label for peripheral neuropathic pain, citing positive Phase 2 results in painful diabetic peripheral neuropathy (DPN).[2]

See also

References

  1. ↑ 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.
  2. 1 2 3 4 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.
  3. ↑ Kolata, Gina (30 January 2024). "Experimental Drug Cuts Off Pain at the Source, Company Says". The New York Times. Retrieved 31 January 2024.
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