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# Vertex NDA for Pain Drug Accepted for Review
- URL: https://www.fdaweb.com/vertex-nda-for-pain-drug-accepted-for-review/
- Published: 2024-07-30T12:00:00.000Z
- Updated: 2026-09-14T14:36:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157464

FDA has accepted for review a Vertex Pharmaceuticals NDA for suzetrigine, a selective NaV1.8 pain signal inhibitor for treating moderate-to-severe acute pain. “Suzetrigine has the potential to be the first new class of medicine to treat acute pain in over 20 years,” the company says, adding that non-opioid drug submission was granted a priority review and given a 1/30/2025 user fee review action target date.

Vertex says NaV1.8 is a “voltage-gated sodium channel that is selectively expressed in peripheral pain-sensing neurons (nociceptors), where its role is to transmit pain signals (action potentials). NaV1.8 is a genetically validated target for the treatment of pain, and suzetrigine has demonstrated a favorable benefit/risk profile in three Phase 3 studies and two Phase 2 studies in patients with moderate-to-severe acute pain.” It says the drug also demonstrated a well-tolerated profile in a Phase 2 study in patients with pain associated with diabetic peripheral neuropathy, a type of chronic peripheral neuropathic pain.