Safinamide NDA Resubmitted for Parkinson's Disease
Newron announced the resubmission of its New Drug Application (NDA) for safinamide to the Food and Drug Administration (FDA).
The safinamide NDA covers its indications 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.
The first NDA submission from May 2014 was refused due to organizational and navigational problems such as hyperlinking of tables, folders, and the organization of the table of contents in the submission.
Safinamide, an alpha-aminoamide, is presumed 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.