Positive Phase 3 Results for Vertex's VX-548 in Treating Moderate-to-Severe Acute Pain

Vertex Pharmaceuticals has reported positive outcomes from its Phase 3 clinical trials for VX-548, a selective NaV1.8 inhibitor intended for the treatment of moderate-to-severe acute pain. The trials encompassed two pivotal studies following abdominoplasty and bunionectomy surgeries, along with a single-arm study involving patients with various surgical and non-surgical pain conditions. VX-548 demonstrated significant pain reduction compared to placebo and was well-tolerated with a favorable safety profile.

In the abdominoplasty and bunionectomy trials, VX-548 significantly outperformed placebo on the primary endpoint, which measured the time-weighted sum of pain intensity difference from 0 to 48 hours (SPID48). The drug also showed a rapid onset to meaningful pain relief, with a median time to relief of 2 hours in abdominoplasty and 4 hours in bunionectomy patients, compared to 8 hours for placebo in both studies.

However, the trials did not meet the first key secondary endpoint, which hypothesized that VX-548 would be superior to hydrocodone bitartrate/acetaminophen (HB/APAP) on SPID48 following the surgeries. The second key secondary endpoint, measuring time to meaningful pain relief, favored VX-548 over placebo.

In the single-arm study, VX-548 showed effectiveness and safety over a 14-day treatment period across a range of pain conditions. The drug was rated positively by 83.2% of patients in a Patient Global Assessment (PGA) at the end of treatment.

Vertex Pharmaceuticals plans to submit a New Drug Application to the FDA by mid-2024, aiming to secure a broad label for VX-548 in treating acute pain. The company has already received Breakthrough Therapy and Fast Track designations for VX-548 in the U.S. for acute pain treatment.

The positive results from the VX-548 trials are promising, positioning the drug as a potential non-opioid alternative for acute pain management. The CEO of Vertex, Reshma Kewalramani, highlighted the drug's efficacy and safety, noting its potential to fill the gap between medications with limited efficacy and those with known risks, such as opioids. Jessica Oswald, a physician and member of Vertex's Acute Pain Steering Committee, echoed the sentiment, emphasizing the need for new, safe, and effective pain treatment options.

Vertex Pharmaceuticals is committed to advancing its pain portfolio, with ongoing development of additional NaV1.8 and NaV1.7 inhibitors for acute and neuropathic pain. The company also plans to discuss the VX-548 results and next steps in a conference call scheduled for January 30, 2024.