Vertex receives Breakthrough Therapy designation from FDA for VX-150

Vertex announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to VX-150 for the treatment of moderate-to-severe acute pain. Breakthrough Therapy designation is designed to expedite the development and review of drugs that are intended to treat a serious condition and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint or endpoints. Vertex recently initiated a Phase 2b dose-ranging study evaluating VX-150 in patients with acute pain following bunionectomy surgery. The study is designed to evaluate multiple oral doses of VX-150 to potentially support pivotal development. Vertex now has positive Phase 2 data for VX-150 in multiple pain conditions, including chronic pain caused by osteoarthritis and small fiber neuropathy, as well as acute pain following bunionectomy surgery. The company continues to invest in the discovery and development of other potential pain molecules that target NaV1.8 and other new pain mechanisms and anticipates initiating clinical development with the first of these molecules in 2019.
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