Publication of VX 548 positive phase II, proof-of-concept results in New England Journal of Medicine.- Vertex
Vertex Pharmaceuticals Incorporated announced publication in the New England Journal of Medicine (NEJM) of preclinical data and the results from its Phase II proof-of-concept trials evaluating treatment with the selective, oral NaV1.8 inhibitor VX 548 for acute pain following abdominoplasty and bunionectomy surgeries.
“VX 548 preclinical studies demonstrated high selectivity and potency for the NaV1.8 sodium channel which translated into Phase II clinical results with strong efficacy, a favorable benefit-risk profile and promise in the treatment of acute pain,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. “Our Phase III trials for VX 548 are well underway, and we look forward to the potential of bringing an effective, non-opioid therapeutic option to patients suffering from moderate to severe acute pain.”
Acute pain is frequently treated with opioids that come with significant safety and tolerability concerns, including sedation, respiratory depression and the potential for misuse and addiction,” said Scott Weiner, M.D., M.P.H., co-author of the NEJM manuscript, Associate Professor of Emergency Medicine at Harvard Medical School and Attending Emergency Physician in the Department of Emergency Medicine at Brigham and Women’s Hospital. “There has not been a new class of pain medicine in decades, and we urgently need new treatment options to help the millions of people affected by pain each year in the U.S. The Phase II results from VX 548 show the potential this medicine could bring to patients.”
Vertex expects to complete the pivotal program in late 2023 and share results from these studies in late 2023 or early 2024. VX 548 has been granted Breakthrough Therapy and Fast Track designations in the U.S. for moderate to severe acute pain. In addition, Vertex has initiated a Phase II dose-ranging study of VX 548 in neuropathic pain.
See - "Selective Inhibition of NaV1.8 with VX 548 for Acute Pain"- Jim Jones, M.D., Pharm.D., Darin J. Correll, M.D., Sandra M. Lechner, Ph.D., Ina Jazic, Ph.D., Xiaopeng Miao, Ph.D., David Shaw, Ph.D., et al., for the VX21-548-101 and VX21-548-102 Trial Groups. August 3, 2023 .N Engl J Med 2023; 389:393-405 . DOI: 10.1056/NEJMoa2209870.
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