FDA to Review Investigational Parkinson's Disease Drug Xadago
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.
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.
For more information visit Newron.com.