Novel Adjunct Agent Approved for Parkinson’s "Off" Periods

Wednesday, March 22, 2017 | FDA Approval/Clearance , Movement Disorders


The FDA approved Xadago (safinamide, Newron Pharmaceuticals) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. The approval is based on results from a clinical trial in which 645 patients receiving safinamide in addition to levodopa experienced more beneficial “on” time, when Parkinson’s symptoms are reduced. The increase in “on” time was accompanied by a reduction in “off” time and better motor function scores during “on” time than before treatment, according to the results.

            According to Laxman Bahroo, DO, Associate Professor of Neurology at Georgetown University and editorial member for Practical Neurology®, safinamide is a welcome addition to the therapeutic armamentarium for Parkinson’s disease. "Safinamide is a novel MAO-B inhibitor that reduces off time and improves on time without troublesome dyskinesia,” says Dr. Bahroo. “Maintaining on time without worsening dyskinesia is an unmet need in advancing Parkinson’s disease.”

            The most common adverse events for patients taking Xadago include uncontrolled involuntary movement, falls, nausea, and trouble sleeping. Less common serious side effects include hypertension, serotonin syndrome (when used with MAOIs, antidepressants, or opioid drugs), hallucinations and psychotic behavior, and problems with impulse control or compulsive behaviors. The indication also notes that patients who have severe liver problems or who take dextromethorphan should not take safinamide.     

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