Newron Pharmaceuticals announced the submission of a New Drug Application (NDA) to the FDA for safinamide as add-on therapy to a stable dose of a single dopamine agonist in early Parkinson’s disease and as add-on therapy to levodopa alone or in combination with other Parkinson’s disease treatments in mid-to-late stage Parkinson’s disease.

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Safinamide, an alpha-aminoamide, is believed to have 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.

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