The drug candidate, VX-548, is in a phase 3 trial for moderate to severe acute pain at Vertex Pharmaceuticals. Forty-eight hours after abdominoplasty or bunionectomy surgery, the trial found the medicine reduced pain intensity significantly for both cohorts, plus non-surgical acute pain conditions.
A second goal of the study was to test VX-548’s potential superiority to hydrocodone bitartrate/acetaminophen, but the candidate failed to prove a meaningful difference in results.
Pitted against a placebo, Vertex’s product caused faster pain relief: “The median time to meaningful pain relief was eight hours for placebo in both studies, compared to two hours in abdominoplasty and four hours in bunionectomy for VX-548,” the release said.
After finding strong safety results 14 days after administration, Vertex is planning to seek regulatory approval.
“I look forward to the potential of having a new class of acute pain medicine — the first in more than two decades — to use as an alternative to opioids to help the millions of people impacted by acute pain,” Jessica Oswald, MD, a emergency medicine and pain medicine physician at the University of California San Diego who is also on Vertex’s acute pain steering committee, said in the release.
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