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Drugs
Published in: Drugs 6/2015

01-04-2015 | R&D Insight Report

Safinamide: First Global Approval

Author: Emma D. Deeks

Published in: Drugs | Issue 6/2015

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Abstract

Safinamide (Xadago®) is an oral α-aminoamide derivative developed by Newron for the treatment of Parkinson’s disease (PD). The drug has both dopaminergic properties (highly selective and reversible inhibition of monoamine oxidase-B) and non-dopaminergic properties (selective sodium channel blockade and calcium channel modulation, with consequent inhibition of excessive glutamate release). Safinamide is approved in the EU, Iceland, Lichtenstein and Norway, as an add-on therapy to stable-dose levodopa, alone or in combination with other PD therapies in mid- to late-stage fluctuating PD patients; regulatory submissions have also been filed in the USA and Switzerland for its use in this indication. Additional submissions have been made in the USA, Iceland, Lichtenstein, Norway and Switzerland for early-stage PD. Safinamide has also undergone phase II investigation in PD patients with drug-induced dyskinesia (France, Germany, Austria, Canada and South Africa) or cognitive impairment (USA and Spain). This article summarizes the milestones in the development of safinamide leading to its first approval for PD.
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Metadata
Title
Safinamide: First Global Approval
Author
Emma D. Deeks
Publication date
01-04-2015
Publisher
Springer International Publishing
Published in
Drugs / Issue 6/2015
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-015-0389-7

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