– 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)--Jan. 30, 2024-- 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.

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<0.0001); bunionectomy: LS mean difference in SPID48 between VX-548 and placebo = 29.3 (95% CI: 14.0, 44.6; P=0.0002)).

For the first key secondary endpoint, Vertex tested the hypothesis that VX-548 was superior to hydrocodone bitartrate/acetaminophen (HB/APAP) on SPID48 following abdominoplasty surgery or bunionectomy surgery. Neither trial met this key secondary endpoint (abdominoplasty: LS mean difference between VX-548 and HB/APAP = 6.6 (95% CI: -5.4, 18.7; P=0.2781); bunionectomy: LS mean difference between VX-548 and HB/APAP = -20.2 (95% CI: -32.7, -7.7; P=0.0016)).

The second key secondary endpoint in both trials was time to meaningful pain relief defined as ?2-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. (The median time to meaningful pain relief was 8 hours for placebo in both studies compared to 2 hours in abdominoplasty and 4 hours in bunionectomy for VX-548, with nominal P<0.0001 and 0.0016, respectively.)

Other secondary endpoints in both trials were generally consistent with the primary endpoint. see & read more on
https://news.vrtx.com/news-releases/news-release-details/vertex-announces-positive-results-vx-548-phase-3-program