Treatment with VX-548 led to statistically-significant improvement in pain

Vertex Pharmaceuticals (Nasdaq: VRTX) today announced positive results from its Phase III program for the selective non-opioid selective NaV1.8 inhibitor V VX-548, in the treatment of moderate-to-severe acute pain, sending the firm’s shares up as much as 35 TO $44 4.24.

VX-548 is Vertex’ fourth attempt to develop a sodium channel Nav1.8 inhibitor, after VX-128, VX-150 and VX-961 failed to impress. VX-548 is also being tested in people with painful diabetic peripheral neuropathy (DPN).

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)).