What is Vimpat?
Vimpat is a medicine containing the active substance lacosamide and is available as oval-shaped tablets (pink: 50 mg; yellow: 100 mg; salmon: 150 mg; blue: 200 mg), as a syrup (15 mg / ml) and as a solution. for the preparation of infusions (drip into a vein, 10 mg / ml).
What is Vimpat used for?
Vimpat is used to treat partial seizures (seizures originating from a specific area of the brain) and as an add-on to other antiepileptic medicines in patients aged 16 years or older. It can be used in patients with partial seizures with or without secondary generalization (ie subsequent spread of the attack to the whole brain).
The medicine can only be obtained with a prescription.
How is Vimpat used?
Vimpat is taken twice a day with or without food. The recommended starting dose is 50 mg twice a day. After one week, the dose should be increased to 100 mg twice a day; thereafter, based on the patient's response, it can be further increased each week by 50 mg twice daily up to a maximum dose of 200 mg twice daily. To facilitate the initiation of treatment, a special pack is provided containing tablets in all four strengths available. Lower doses can be used in patients with kidney problems. If the patient is temporarily unable to take the tablets or syrup, Vimpat can be given in the same dose by infusion lasting between 15 minutes and one hour. However, this administration can only last for a few days.
How does Vimpat work?
The active substance in Vimpat, lacosamide, is an anti-epileptic drug. Epilepsy is caused by excessive electrical activity in the brain. The precise mode of action of lacosamide is not yet clear, however it appears to reduce the activity of sodium channels (pores on the surface of neurons) that allow the transmission of electrical impulses between neurons. Lacosamide is also believed to be involved in development of neurons that have been damaged.The combination of these actions can prevent the spread of abnormal electrical activity throughout the brain, reducing the chances of a seizure.
How has Vimpat been studied?
The effects of Vimpat were first tested in experimental models before being studied in humans.
The effectiveness of Vimpat taken by mouth was compared with that of placebo (a dummy treatment) in three main studies involving a total of 1308 patients. Patients were given Vimpat at a dose of 200 mg, 400 mg or 600. mg per day, or placebo, in addition to ongoing treatment including up to 3 other antiepileptics.The main measure of effectiveness was the number of patients whose number of seizures was at least halved after 12 weeks of stable dose treatment.
Two other studies, involving a total of 199 patients, looked at the most appropriate duration for infusion of the Vimpat solution, comparing its safety to infusion with placebo.
What benefit has Vimpat shown during the studies?
Vimpat, at a dose of 200 or 400 mg per day, was more effective than placebo in reducing the number of attacks. Taken together, the results of the three main studies indicate that 34% of patients who added Vimpat 200 mg / day and 40% of patients who added Vimpat 400 mg / day to their current treatment achieved a reduction in the number of attacks. equal to at least 50%. The similar value obtained with the addition of placebo was 23%. The 600 mg dose showed the same efficacy as the 400 mg dose, however with more side effects.
What is the risk associated with Vimpat?
The most common side effects associated with Vimpat (i.e. those seen in more than 1 in 10 patients) are dizziness, headache, diplopia (double vision) and nausea. For the full list of side effects reported with Vimpat, see the package leaflet.
Vimpat should not be used by people who may be hypersensitive (allergic) to lacosamide or any of the other ingredients or with second or third degree atrioventricular block (a heart rhythm disorder). Vimpat tablets should not be used in people who are hypersensitive to peanuts or soy.
Why has Vimpat been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Vimpat's benefits are greater than its risks as adjunctive therapy for partial seizures with or without secondary generalization in epileptic patients aged 16 years and over. The committee recommended the granting of a marketing authorization for Vimpat.
Other information about Vimpat:
On 29 August 2008, the European Commission issued UCB Pharma S.A. a "marketing authorization" for Vimpat, valid throughout the European Union.
For the full version of Vimpat's EPAR, click here.
Last update of this summary: 07-2008.
The information on Vimpat - lacosamide published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
