Italy’s Newron files Parkinson’s drug with FDA

New Drug Approvals


cas  202825-46-5 (mesylate)


Newron Pharmaceuticals and fellow Italy-headquartered partner Zambon have filed their investigational Parkinson’s disease treatment safinamide with regulators in the USA.

The submission to the US Food and Drug Administration is for safinamide as add-on therapy in early and mid-to late stage PD patients. Newron said the filing was based on “completion of activities agreed upon during meetings” with the FDA, noting that a marketing authorisation application was submitted to the European Medicines Agency in December.

Read more at:

133865-89-1, Fce 26743, AC1L2ZLK, CHEMBL396778, MolPort-005-942-375,
Fce-26743, (S)-2-((4-((3-Fluorobenzyl)oxy)benzyl)amino)propanamide
Molecular Formula: C17H19FN2O2   Molecular Weight: 302.343363

Safinamide (EMD 1195686) is a candidate drug against Parkinson’s disease with multiple methods of action.[1] In 2007, a Phase III clinical trial was started. It was scheduled to run until 2011.[2] The compound was originally discovered at Farmitalia-Carlo…

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