Suzetrigine

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. It is being developed by Vertex Pharmaceuticals and has completed two Phase III trials.

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.

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.

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