Newron Pharmaceuticals S.p.A. (Newron), a research and development company, and its partner Zambon S.p.A., an international pharmaceutical company, have announced that the New Drug Application (NDA) for safinamide was submitted to the US Food and Drug Administration (FDA).

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 based on completion of activities agreed upon during meetings with the FDA.

The submission was made by Newron, which is the NDA holder until completion of the sublicense process for the US rights to safinamide, by Zambon.

Stefan Weber, Newron's CEO, commented: "We are both proud and excited to be submitting the company's first ever NDA, for safinamide. Parkinson's disease is a debilitating condition and this brings us one crucial step closer to providing an innovative treatment to improve the quality of life for these patients."

Ravi Anand, Newron's CMO, commented: "Following the usual review periods, we are optimistic that safinamide will receive approval within Europe by end of this year, and in the US within 12 months. After submission of the filings in the European Union, the US and Switzerland, we will now support filings in additional territories based on the US and EU documentation, as planned by our partners."

Maurizio Castorina, Zambon Pharma CEO, stated: "Zambon is strongly committed to preparing the launch of safinamide in territories core to its strategy, and to advancing and completing the licensing process for additional territories, including the US. We are convinced that safinamide will bring benefits to both patients and Health Authorities alike."

Marco Sardina, Zambon Pharma CSO, added: "There is still a strong medical need for new, safer therapies to effectively treat motor symptoms and motor complications of Parkinson's disease patients. Zambon and its sublicencees will take the actions required to fully exploit the innovative therapeutic potential of safinamide."

Safinamide, an alpha-aminoamide, is currently being developed by Newron as an add-on therapy to dopamine agonists 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.

Newron is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the Central Nervous System (CNS) and pain.

Zambon is a leading Italian pharmaceutical and fine-chemical multinational company, that has earned a strong reputation over the years for high quality products and services. Zambon is well-established in 3 therapeutic areas: respiratory, pain and woman care, and is very strongly committed to its entry into the CNS space.