Vertex Pharmaceuticals reports positive Phase 3 results of VX-548 in acute pain

Vertex Pharmaceuticals announced positive results from its Phase 3 program for the selective NaV1.8 inhibitor, VX-548, in the treatment of moderate-to-severe acute pain. The Phase 3 program included two pivotal trials, one following abdominoplasty surgery and one following bunionectomy surgery, as well as a single arm safety and effectiveness study. Treatment with VX-548 following abdominoplasty or bunionectomy surgery resulted in a statistically significant improvement on the primary endpoint of the time-weighted sum of the pain intensity difference from 0 to 48 hours vs. placebo as well as a clinically meaningful reduction in pain from baseline at 48 hours in both studies. Neither trial met the key secondary endpoint of time to meaningful pain relief defined as greater than or equal to2-point reduction in NPRS from baseline compared to placebo. VX-548 had a more rapid onset to meaningful pain relief than placebo in both the abdominoplasty and bunionectomy trials. Other secondary endpoints in both trials were generally consistent with the primary endpoint. The Phase 3 single arm safety and effectiveness study evaluated treatment with VX-548 across a broad range of other surgical and non-surgical acute pain conditions and demonstrated favorable safety and tolerability. VX-548 was safe and well tolerated in all three Phase 3 studies. Vertex plans to submit a New Drug Application to the FDA by mid-2024 with the goal of achieving a broad label in moderate-to-severe acute pain. VX-548 has secured Breakthrough Therapy and Fast Track designations in the U.S. for acute pain. In addition, Vertex seeks to achieve a broad label in peripheral neuropathic pain. Vertex has also initiated a Phase 2 peripheral neuropathic pain study of VX-548 in patients with painful lumbosacral radiculopathy, or LSR, which is pain caused by impairment or injury to nerve roots in the area of the lumbar spine.