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# Vertex Moving Neuropathy Pain Drug to Phase 3
- URL: https://www.fdaweb.com/vertex-moving-neuropathy-pain-drug-to-phase-3/
- Published: 2023-12-13T12:00:00.000Z
- Updated: 2026-09-14T14:18:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155982

Vertex Pharmaceuticals says it will advance selective NaV1.8 inhibitor VX-548 into pivotal Phase 3 studies after it discusses with FDA and other regulators “positive results” from its Phase 2 dose-ranging study in people with painful diabetic peripheral neuropathy (DPN). “Treatment with all doses of VX-548 resulted in a statistically significant and clinically meaningful reduction in the primary endpoint of change from baseline in the weekly average of daily pain intensity on a Numeric Pain Rating Scale (NPRS) at Week 12,” it says. VX-548 was found to be well tolerated at all doses tested, and most adverse events were mild to moderate and there were no serious adverse events related to the drug, it adds.

The study’s primary endpoint was change from baseline in the weekly average of daily pain intensity at Week 12 in patients with painful DPN dosed with VX-548 using the NPRS measure. “All VX-548 treatment groups showed statistically significant and clinically meaningful reductions from baseline in pain with mean change in NPRS at Week 12 of -2.26, -2.11 and -2.18 at the high, mid and low doses, respectively,” Vertex says.

“Given the favorable benefit/risk profile of VX-548 seen in this study, we are working with urgency to advance this investigational non-opioid pain medicine into Phase 3 in painful diabetic neuropathy with the goal of changing the standard of care for neuropathic pain, where treatment options are limited,” Vertex says. “In addition, our Phase 3 studies of VX-548 in acute pain are on track to read out in the first quarter of 2024.”

VX-548 is described as a selective NaV1.8 inhibitor that is highly selective for NaV1.8 relative to other NaV channels. “NaV1.8 is a voltage-gated sodium channel that plays a critical role in pain signaling in the peripheral nervous system,” the company says. “NaV1.8 is a genetically validated target for the treatment of pain, and Vertex has previously demonstrated positive proof-of-concept results and a well-tolerated profile with VX-548 in two Phase 2 studies of acute pain following abdominoplasty and bunionectomy surgeries.”