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]
 | |
| Clinical data | |
|---|---|
| Other names | VX-548 |
| Legal status | |
| Legal status |
|
| Identifiers | |
| |
| CAS Number | |
| PubChem CID | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C21H20F5N3O4 |
| Molar mass | 473.400 g·mol−1 |
| 3D model (JSmol) | |
| |
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 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.[5]
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
editReferences
edit- ^ a b c "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.
- ^ a b c 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". [Vertex Pharmaceuticals | Press]. 30 July 2024. Retrieved 20 October 2024.