Newron Pharmaceuticals and Zambon S.p.A. announced  that the FDA has accepted for filing the New Drug Application (NDA) for Xadago (safinamide) as add-on therapy in both early and mid-to-late stage Parkinson’s disease (PD) patients who are inadequately managed on their current treatment.

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Xadago, an alpha-aminoamide, is currently being developed as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid-to-late stage Parkinson’s disease. It has both dopaminergic and non-dopaminergic activities, including selective and reversible inhibition of monoamine oxidase B (MAO-B), activity-dependent sodium channel antagonism, and inhibition of glutamate release in vitro.

The FDA has set a target date of December 29, 2015 to complete its review of the NDA.

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