Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) has reported positive outcomes from its Phase 3 program for VX-548, a selective NaV1.8 inhibitor, designed to address moderate-to-severe acute pain. The Phase 3 program encompassed two pivotal trials following abdominoplasty and bunionectomy surgery, as well as a safety and effectiveness study with patients experiencing various surgical and non-surgical acute pain conditions.
Following abdominoplasty or bunionectomy surgery, treatment with VX-548 demonstrated statistically significant improvement in the primary endpoint, the time-weighted sum of the pain intensity difference from 0 to 48 hours (SPID48), compared to placebo. Additionally, a clinically meaningful reduction in pain from baseline at 48 hours was observed on the Numeric Pain Rating Scale (NPRS) in both studies.
For the key secondary endpoint, comparing VX-548 to hydrocodone bitartrate/acetaminophen (HB/APAP), neither trial met the criterion of superiority on SPID48. However, VX-548 exhibited a more rapid onset to meaningful pain relief compared to placebo in both the abdominoplasty and bunionectomy trials.
The Phase 3 single arm safety and effectiveness study, spanning up to 14 days across diverse acute pain conditions, showed favorable safety, tolerability, and effectiveness measured by Patient Global Assessment (PGA) at the end of treatment. VX-548 was well-tolerated in all three Phase 3 studies, with a lower incidence of adverse events (AEs) than placebo in the randomized controlled trials.
Reshma Kewalramani, M.D., CEO and President of Vertex, emphasized the potential of VX-548 to address the gap between medicines with limited efficacy and opioids with known risks. With FDA Breakthrough and Fast Track Designations, Vertex plans to file the New Drug Application for VX-548, aiming to provide an alternative to opioids for millions suffering from acute pain.
Jessica Oswald, M.D., M.P.H., Associate Physician in Emergency Medicine and Pain Medicine at the University of California San Diego, and Vertex Acute Pain Steering Committee Member, highlighted the impressive safety and efficacy of VX-548, expressing anticipation for a new class of acute pain medicine that could revolutionize pain management, offering an alternative to opioids after more than two decades.