Vertex Announces Positive Results From the VX-548 Phase 3 Program for the Treatment of Moderate-to-Severe Acute Pain

– Treatment with VX-548 led to statistically significant improvement in pain compared to placebo as well as a clinically meaningful reduction in pain from baseline in both the abdominoplasty and bunionectomy randomized controlled trials –

– Treatment with VX-548 was also shown to be effective in the single arm study in a broad range of surgical and non-surgical pain conditions for up to 14 days –

– VX-548 was safe and well tolerated in all three studies –

– Vertex plans to submit a New Drug Application to the FDA by mid-2024 –

– Vertex to host investor call January 30 at 8:00 a.m. ET –

BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today 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 randomized, double-blind, placebo-controlled, pivotal trials, one following abdominoplasty surgery and one following bunionectomy surgery, as well as a single arm safety and effectiveness study which enrolled patients with a broad range of surgical and non-surgical pain conditions.

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Figure 1: Mean NPRS Over Time in Phase 3 Study of Acute Pain Following Abdominoplasty (Graphic: Business Wire)

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 (SPID48) compared to placebo as well as a clinically meaningful reduction in pain from baseline at 48 hours on the Numeric Pain Rating Scale (NPRS) in both studies (abdominoplasty: LS mean difference in SPID48 between VX-548 and placebo = 48.4 (95% CI: 33.6, 63.1; P