Daniel Grizelj
Vertex Pharmaceuticals (NASDAQ:VRTX) is trading around +6.5% premarket on Tuesday after it reported positive results from a Phase 3 program evaluating VX-548, its non-opioid drug candidate for moderate to severe acute pain.
VX-548 was found to significantly improve pain compared to placebo treatment in post-operative pain in abdominoplasty and bunionectomy randomized controlled trials. It was found to be effective in treating surgical and non-surgical pain conditions for up to 14 days.
The new class of acute pain medicine was safe and well tolerated in all three studies and Vertex (VRTX) plans to submit a new drug application to the U.S. FDA by mid-2024. VX-548 already has FDA breakthrough and fast track designations.
CEO Reshma Kewalramani said: “The VX-548 benefit-risk profile ideally positions it to potentially fill the gap between medicines with good tolerability but limited efficacy and opioid medicines with therapeutic efficacy but known risks, including addictive potential.”
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