Xadago - safinamide
What is Xadago and what is it used for?
Xadago is a medicine used to treat adult patients with Parkinson's disease, a progressive mental disorder that causes tremor, slow movement and muscle stiffness. It is used in combination with levodopa (a medicine usually used to treat the symptoms of Parkinson's disease), alone or in combination with other medicines for Parkinson's disease, in people in the intermediate to advanced stages of the disease who experience "motor fluctuations ". These fluctuations occur when the effect of levodopa wears off and the patient suddenly changes from the 'on' state, where he is able to move, to the 'off' state of difficult mobility. Xadago containing the active substance safinamide.
How is Xadago used - safinamide?
Xadago is available as tablets (50 and 100 mg) and can only be obtained with a prescription. Treatment should be started at a dose of 50 mg per day and the doctor should increase the dose up to 100 mg per day, according to the patient's needs. For more information, see the package leaflet.
How does Xadago - safinamide work?
In patients with Parkinson's disease, certain dopamine-producing brain cells die and, because dopamine controls movement, patients' mobility worsens over time. The active substance in Xadago, safinamide, is a 'monoamine oxidase-B (MAO-B) inhibitor'. It blocks the monoamine oxidase type B enzyme, which is responsible for the breakdown of dopamine, thereby helping to restore dopamine levels in the brain and improving the patient's symptoms.
What benefit has Xadago - safinamide shown during the studies?
Xadago, used as add-on therapy to levodopa with or without other medicines for Parkinson's disease, has been compared with placebo (a dummy treatment) in two main studies involving 1,218 patients with end-stage Parkinson's disease, which reported motor fluctuations. In both studies, use of Xadago therapy for 6 months increased the length of the “on” phase in which patients were able to move by 30-60 minutes compared to placebo. the maintenance of this effect for 24 months. Xadago was also studied as an adjunct to the main treatment in 2 studies in subjects with early Parkinson's disease and without motor fluctuations. However, no obvious benefit emerged from these studies and the company decided to forgo this indication as part of the application for authorization.
What is the risk associated with Xadago - safinamide?
The most common side effects with Xadago (which may affect up to 1 in 10 people) are insomnia, dyskinesia (difficulty in controlling movement), sleepiness, numbness, headache, worsening of current Parkinson's disease, cataracts (blurred crystalline), orthostatic hypotension (drop in blood pressure upon transition to standing), nausea and falls. For the full list of all side effects reported with Xadago, see the package leaflet. Xadago must not be used in patients with severe liver problems, in people treated with pethidine or other medicines that inhibit MAO, or in patients with certain disorders For the full list of restrictions, see package leaflet.
Why has Xadago - safinamide been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Xadago's benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee concluded that the effect of Xadago on time spent daily without patients experiencing motor symptoms was clinically significant, even taking into account the response reported in the literature for other drugs used in the treatment of Parkinson's disease. Furthermore, the effect was also maintained in the long term. As for safety, it was considered acceptable overall.
What measures are being taken to ensure the safe and effective use of Xadago - safinamide?
A risk management plan has been developed to ensure that Xadago is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Xadago, including the appropriate precautions to be followed by healthcare professionals and patients. Further information can be found in the summary of the risk management plan.
More information about Xadago - safinamide
On 24 February 2015, the European Commission granted a "Marketing Authorization" for Xadago, valid throughout the European Union. For more information on Xadago therapy, read the package leaflet (included with the EPAR) or consult your doctor. or the pharmacist. Last update of this summary: 02-2015.
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