Vertex Pharmaceuticals said its pivotal Phase 3 study of VX-548, a selective NaV1.8 inhibitor, met its primary endpoint in patients with painful diabetic peripheral neuropathy (DPN). The study found a statistically significant and clinically meaningful reduction in the weekly average of daily pain intensity compared with placebo.
The results mark a step forward for a potential non-opioid treatment for a condition affecting millions of people. Analysts are optimistic about the drug’s potential, citing the high unmet need for effective and safe pain relief in this patient population.
Vertex plans to submit a New Drug Application to the FDA in the first half of 2027.