NDA Resubmitted to FDA for New Parkinson's Disease Drug
NDA Resubmitted for New Parkinson's Disease Drug
Newron Pharmaceuticals has resubmitted its New Drug Application (NDA) for safinamide to the 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 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.
"Newron has been in frequent contact with the FDA to propose solutions to the technical issues and obtain their concurrence with the proposals," Newron Chief Medical Officer Ravi Anand said in a statement. "These discussions lead Newron to conclude that the [Refusal to File] issues have been addressed in this submission."