Daniele Grizelj
Vertex Pharmaceuticals (NASDAQ:VRTX) is trading around +6.5% on Tuesday, after reporting 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 Postoperative pain treatment in randomized controlled trials of abdominoplasty and bunionectomy. It has been found to be effective in treating surgical and non-surgical pain conditions for up to 14 days.
The new class of acute pain medications was found to be 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 has already achieved groundbreaking and accelerated designations from the FDA.
CEO Reshma Kewalramani said: “VX-548’s benefit-risk profile positions it ideally to potentially bridge the gap between drugs with good tolerability but limited efficacy and opioid drugs with therapeutic efficacy but known risks, including the potential for addiction.” .