NDA for New Parkinson's Drug Accepted by the FDA
NDA for New Parkinson's Drug Accepted by FDA
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 patients who are inadequately managed on their current treatment.
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.
"We are in late stage negotiations with interested potential partners for Xadago in the U.S.,” Zambon CEO Maurizio Castorina said in a statement. “And subject to FDA approval, Zambon expects the commercial launch of this New Chemical Entity by our North American partner in the first quarter of 2016.”
The companies resubmitted the NDA in December after 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.