ParkinsonCanadaV1, PubMed, Curation, bibRecord, 000527

Safinamide: first global approval.

Identifieur interne : 000527 ( PubMed/Curation ); précédent : 000526; suivant : 000528

Safinamide: first global approval.

Auteurs : Emma D. Deeks [Oman]

Source :

Drugs [ 1179-1950 ] ; 2015.

RBID : pubmed:25851099

English descriptors

KwdEn :
- Alanine (adverse effects), Alanine (analogs & derivatives), Alanine (pharmacokinetics), Alanine (therapeutic use), Animals, Antiparkinson Agents (adverse effects), Antiparkinson Agents (pharmacokinetics), Antiparkinson Agents (therapeutic use), Benzylamines (adverse effects), Benzylamines (pharmacokinetics), Benzylamines (therapeutic use), Cognition Disorders (drug therapy), Drug Approval, Dyskinesia, Drug-Induced (drug therapy), Humans, Internationality, Parkinson Disease (drug therapy).
MESH :
- chemical , adverse effects : Alanine, Antiparkinson Agents, Benzylamines.
- chemical , analogs & derivatives : Alanine.
- chemical , pharmacokinetics : Alanine, Antiparkinson Agents, Benzylamines.
- chemical , therapeutic use : Alanine, Antiparkinson Agents, Benzylamines.
- drug therapy : Cognition Disorders, Dyskinesia, Drug-Induced, Parkinson Disease.
- Animals, Drug Approval, Humans, Internationality.

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.

DOI: 10.1007/s40265-015-0389-7
PubMed: 25851099

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Le document en format XML

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<front><div type="abstract" xml:lang="en">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.</div>
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Safinamide: first global approval.

Safinamide: first global approval.

Source :

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Links to Exploration step

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

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Pour générer des pages wiki