The U.S. Food and Drug Administration has approved Newron Pharmaceuticals’s Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa.
FDA explained that the efficacy of Xadago in treating Parkinson’s disease was shown in a clinical trial of 645 participants who were also taking levodopa and were experiencing decreased functioning (“off” time). Those receiving Xadago experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo.
According to National Institutes of Health 50,000 Americans are diagnosed with Parkinson’s disease each year and about one million Americans have the condition.
C. Warren Olanow, M.D. FRCPC, FRCP(HON), stated: “The approval of Xadago as a treatment for patients with Parkinson’s disease by the FDA represents an important milestone as it is the first New Chemical Entity approved for the treatment of Parkinson’s disease in the USA in over a decade.” Dr. Olanow, Professor and Chairman Emeritus of the Department of Neurology and Professor Emeritus of the Department of Neuroscience at the Mount Sinai School of Medicine in New York City continued, “Xadago as an add-on to levodopa/carbidopa provided a significant reduction in OFF time and a significant increase in ON time without troublesome dyskinesia in PD patients experiencing motor fluctuations.”
Ravi Anand, Newron’s CMO, commented: “International, randomized, clinical trials have demonstrated that Xadago significantly improves ON time, OFF time, and Parkinsonism compared to standard of care without increasing time spent with troublesome dyskinesia in patients experiencing motor fluctuations while on optimized levodopa/carbidopa therapy. Additionally, the onset of improvement of motor fluctuations occurred early in treatment.”
Newron Pharmaceuticals developed the drug together with its partners Zambon S.p.A. and US WorldMeds, LLC.