Parkinson's Disease patients now have a new treatment add-on to help control "off" episodes; XADAGO (safinamide), a once-daily tablet, has been approved for use in the U.S.
Partners Newron Pharmaceuticals S.p.A. and Zambon S.p.A., and US WorldMeds made the announcement. US WorldMeds licensed the medication from Zambon for U.S. distribution.
“The approval of XADAGO offers an important new treatment option for the Parkinson’s community," Boca Raton Institute for Neurodegenerative Disorders Director Dr. Stuart Isaacson said. "XADAGO is the first New Chemical Entity approved for the treatment of PD-related motor fluctuations in the U.S. in over a decade. In clinical trials, patients on once-daily XADAGO demonstrated significant improvement in ‘on’ time without troublesome dyskinesia.”
Two six-month clinical trials with more 1,100 Parkinson's participants found that patients taking levodopa/carbidopa and experiencing "off" time when the medication was not controlling the Parkinson's symptoms benefited from the addition of XADAGO. XADAGO is a monoamine oxidase type B (MAO-B) inhibitor that increased the "on" time without dyskinesia, or difficulty controlling voluntary movements.
“We are very excited to be launching XADAGO,” US WorldMeds CEO P. Breckinridge Jones said. “Part of US WorldMeds’ mission is to develop and market meaningful and accessible healthcare products that improve lives and result in a thriving community of patients. We are confident that XADAGO will progress that mission by providing a new treatment option to Parkinson’s patients."
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