Safinamide: first global approval.
Identifieur interne : 000538 ( Main/Exploration ); précédent : 000537; suivant : 000539Safinamide: first global approval.
Auteurs : Emma D. Deeks [Oman]Source :
- Drugs [ 1179-1950 ] ; 2015.
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
Affiliations:
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Le document en format XML
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Deeks</name><affiliation wicri:level="1"><nlm:affiliation>Springer, Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand, dru@adis.com.</nlm:affiliation><country wicri:rule="url">Oman</country><wicri:regionArea>Springer, Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand</wicri:regionArea><wicri:noRegion>New Zealand</wicri:noRegion></affiliation></author></analytic><series><title level="j">Drugs</title><idno type="eISSN">1179-1950</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Alanine (adverse effects)</term><term>Alanine (analogs & derivatives)</term><term>Alanine (pharmacokinetics)</term><term>Alanine (therapeutic use)</term><term>Animals</term><term>Antiparkinson Agents (adverse effects)</term><term>Antiparkinson Agents (pharmacokinetics)</term><term>Antiparkinson Agents (therapeutic use)</term><term>Benzylamines (adverse effects)</term><term>Benzylamines (pharmacokinetics)</term><term>Benzylamines (therapeutic use)</term><term>Cognition Disorders (drug therapy)</term><term>Drug Approval</term><term>Dyskinesia, Drug-Induced (drug therapy)</term><term>Humans</term><term>Internationality</term><term>Parkinson Disease (drug therapy)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Alanine</term><term>Antiparkinson Agents</term><term>Benzylamines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Alanine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en"><term>Alanine</term><term>Antiparkinson Agents</term><term>Benzylamines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Alanine</term><term>Antiparkinson Agents</term><term>Benzylamines</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Cognition Disorders</term><term>Dyskinesia, Drug-Induced</term><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Animals</term><term>Drug Approval</term><term>Humans</term><term>Internationality</term></keywords></textClass></profileDesc></teiHeader><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></front></TEI><affiliations><list><country><li>Oman</li></country></list><tree><country name="Oman"><noRegion><name sortKey="Deeks, Emma D" sort="Deeks, Emma D" uniqKey="Deeks E" first="Emma D" last="Deeks">Emma D. Deeks</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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