VX-548 FDA Approval Status
Last updated by Carmen Pope, BPharm on March 12, 2024.
FDA Approved: No
Brand name: VX-548
Generic name: suxetrigine
Dosage form: oral tablet
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Neuropathic Pain, Pain, Postoperative Pain
VX-548 (suxetrigine) is an experimental analgesic that is currently undergoing investigational trials to assess its ability to relieve moderate to severe acute pain or peripheral neuropathic pain. VX-548 works by selectively blocking an ion channel (Nav1.8).
- Advances in understanding the physiology behind pain have led to a better appreciation of the role ion channels play in this process. There are many different types of ion channels; voltage-gated ion channels (Nav) channels are one type that have been identified as excellent targets for pain management.
- VX-548 is a highly selective inhibitor of Nav1.8, one of three Nav channels (Nav1.7, Nav1.8, Nav1.9) that have the potential to provide pain relief.
- Phase 3 trials have shown significant pain reduction compared to placebo, but non-superiority over hydrocodone bitartrate/acetaminophen.
- VX-548 has a well-tolerated side effect profile. Common side effects include nausea, constipation, headache, and dizziness.
- VX-548 is an oral medication (taken by mouth).
- VX-548 is not yet FDA-approved, but Vertex aims to submit an application by mid-2024 for moderate to severe acute pain, with in the future, peripheral neuropathic pain.
For more information see What is VX-548?
Development timeline for VX-548
Further information
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