Newron Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for safinamide, which is 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.
The NDA 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.
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Newron Pharmaceuticals and its partner Zambon have submitted the NDA based on completion of activities agreed upon during meetings with the FDA. Newron is the NDA holder until completion of the sublicense process for the US rights to safinamide.
Newron chief medical officer Ravi Anand said the company is optimistic that safinamide will receive approval in Europe before the end of the year, and in the US within 12 months.
"After submission of the filings in the EU, the US and Switzerland, the company will now support filings in additional territories based on the US and EU documentation, as planned by our partners," Anand said.
Safinamide is an alpha-aminoamide that is believed to have dopaminergic and non-dopaminergic properties, including selective and reversible inhibition of monoamine oxidase B (MAO-B), activity-dependent sodium channel antagonism and inhibition of glutamate release in vitro.
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By GlobalDataIn December 2013, Zambon submitted a marketing authorisation application to the European Medicines Agency for safinamide for treatment of Parkinson’s disease.
In March this year, the company submitted a marketing authorisation application for the drug to Swissmedic.
