Newron Pharmaceuticals, a research and development company focused on novel CNS and pain therapies, and its partner Zambon S.p.A., a pharmaceutical company strongly committed to the respiratory, primary care and CNS therapeutic areas, announced that the application for authorisation for safinamide has been submitted to Swissmedic.

The submission covers the indications “safinamide as add-on therapy to a stable dose of a single dopamine agonist” in early Parkinson’s disease patients and “safinamide as add-on therapy to levodopa alone or in combination with other Parkinson’s disease treatments” in mid-to late stage Parkinson’s disease patients.

The submission was made by Zambon, who will be the authorisation holder.

Safinamide, an alpha-aminoamide, is being developed by Newron as an add-on therapy to dopamine ago-nists or to levodopa in patients with early or mid- to late-stage Parkinson’s disease (PD). It 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.