What is Xadago - safinamide used for?
Xadago is a medicine indicated for the treatment of adult patients with Parkinson's disease, a progressive mental disorder that causes tremor, slowness of movement and muscle stiffness. It is used in combination with levodopa (a medicine usually used to treat symptoms of Parkinson's disease), either alone or in combination with other medicines for Parkinson's disease, in subjects who are in the intermediate to advanced stage of the disease and who have “motor fluctuations”. ". These fluctuations occur when the levodopa effect is exhausted and the patient suddenly goes from the "on" state, in which he is able to move, to the "off" state of difficult mobility. Xadago containing the active substance safinamide .
How is Xadago - safinamide used?
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 a day and the doctor should increase the dose up to 100 mg a day, depending on the patient's needs. For more information, see the package leaflet.
How does Xadago - safinamide work?
In patients with Parkinson's disease, certain brain cells that produce dopamine die and, as dopamine is responsible for controlling movement, patient mobility worsens over time. The active substance in Xadago, safinamide, is a "monoamine oxidase-B (MAO-B) inhibitor". Blocks the enzyme monoamine oxidase type B, which is responsible for the degradation 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 adjunctive 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 final Parkinson's disease, who reported motor fluctuations. In both studies, the use of Xadago therapy for 6 months increased the duration of the "on" phase in which patients were able to move by 30-60 minutes compared to placebo. Another study demonstrated the maintenance of this effect for 24 months. Xadago has also been studied as an adjunctive therapy to the main treatment in 2 studies in subjects with Parkinson's disease in the initial phase and without motor fluctuations. However, no clear benefit emerged from these studies and the company decided to forgo this indication as part of the authorization application.
What is the risk associated with Xadago - safinamide?
The most common side effects of Xadago (which may affect up to 1 in 10 people) are insomnia, dyskinesia (difficulty in controlling movement), drowsiness, numbness, headache, worsening of Parkinson's disease in progress, cataracts (blurring of the crystalline), orthostatic hypotension (collapse of blood pressure during the transition to the standing position), nausea and falls. For the full list of all side effects reported with Xadago, see the package leaflet. Xadago should not be used in patients with severe liver problems, in patients treated with pethidine or other medicines that inhibit MAO or in patients with certain eye disorders. For the full list of limitations, see the 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 the patients experiencing motor symptoms was clinically significant, even taking into account the reported answer in the literature for other medicines used in the treatment of Parkinson's disease. Furthermore, the effect has been maintained even in the long term. As for security, overall it was considered acceptable.
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 included in the summary of product characteristics and the package leaflet for Xadago, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Xadago - safinamide
On 24 February 2015, the European Commission issued a marketing authorization valid for Xadago, valid throughout the European Union. For more information about treatment with Xadago, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 02-2015.
