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XADAGO (safinamide), antiparkinsonian

NEUROLOGY - New medicinal product
Opinions on drugs - Posted on Apr 18 2016

Reason for request

Inclusion

In combination with levodopa, no clinical benefit when compared with other antiparkinsonians in controlling motor fluctuations in mid- to late-stage patients

 

 

»  XADAGO is a monoamine-oxidase B (MAOB) inhibitor which is indicated in combination with a stable dose of levodopa (L-dopa) alone or in combination with other antiparkinsonian medicines in adult patients with idiopathic, fluctuating Parkinson’s disease in the mid- to late stage of the disease.

 

»  Two randomised double-blind studies have demonstrated its efficacy versus placebo in terms of the improvement in the amount of time spent per day in the ON phase without dyskinesia or with non-troublesome dyskinesia. During the day, the effect observed was of low clinical relevance: safinamide increases from 30 to 60 minutes the period for which patients are in the ON phase, without dyskinesia or without troublesome dyskinesia.

 

»  This is an additional treatment option in the management of patients with Parkinson’s disease with motor fluctuations on a stable dose of L-dopa .

 

 


Actual benefit

Modéré

-


Improvement in actual benefit

V (absence)

Au vu des données disponibles et en l’absence de donnée comparative versus comparateurs actifs, XADAGO n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux autres médicaments antiparkinsoniens utilisés dans la prise en charge des fluctuations motrices au cours de la maladie de Parkinson à un stade intermédiaire ou avancé, en association à la lévodopa utilisée seule ou en association.


Therapeutic use

-

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