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| Other names | VX-548 |
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| Formula | C21H20F5N3O4 |
| Molar mass | 473.400 g·mol |
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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. It is being developed by Vertex Pharmaceuticals and has completed two phase 3 clinical trials.
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.
Vertex Pharmaceuticals announced on July 30, 2024 that the US Food and Drug Administration has accepted a New Drug Application (NDA) for Suzetrigine. The FDA has granted Suzetrigine priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025. Suzetrigine has already been granted FDA Fast Track and Breakthrough Therapy designations for the treatment of moderate-to-severe acute pain.
Vertex Pharmaceuticals also plans to seek a broad label for peripheral neuropathic pain, citing positive phase 2 results in painful diabetic peripheral neuropathy (DPN). The drug is additionally under development for the treatment of radiculopathy and pain in other contexts.
See also
References
- ^ "Suzetrigine - Vertex Pharmaceuticals". AdisInsight. 19 August 2024. Retrieved 24 August 2024.
- 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.
- ^ 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.
- Kolata, Gina (30 January 2024). "Experimental Drug Cuts Off Pain at the Source, Company Says". The New York Times. Retrieved 31 January 2024.
- "Vertex Announces FDA Acceptance of New Drug Application for Suzetrigine for the Treatment of Moderate-to-Severe Acute Pain". . 30 July 2024. Retrieved 20 October 2024.