Author: UCB Pharma SA


Long information

What is it?

Vimpat is a medicine containing the active substance lacosamide. It is available as oval tablets (pink: 50 mg; yellow: 100 mg; salmon: 150 mg; blue: 200 mg), as a syrup (15 mg/ml) and as a solution for infusion (drip into a vein, 10 mg/ml).

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Vimpat is used to treat partial-onset seizures (epileptic fits starting from one specific part of the brain) as an add-on to other antiepileptic medicines in patients with epilepsy aged 16 years and older. It can be used in patients with partial-onset seizures with or without secondary generalisation (where the seizure subsequently spreads to the whole brain).
The medicine can only be obtained with a prescription.

How is it 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 and then, depending on the patient?s response, it may be further increased every week by 50 mg twice a day to the maximum dose of 200 mg twice a day. A special pack with tablets of all four strengths is available to help when initiating treatment. Lower doses may be used in patients who have problems with their kidneys. If the patient is temporarily unable to take the tablets or syrup, Vimpat can be given at the same dose as an infusion lasting 15 minutes to one hour. This should only be used for a few days.

How does it work?

The active substance in Vimpat, lacosamide, is an anti-epileptic medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way in which lacosamide works is still unclear but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells. Lacosamide is also thought to be involved in the development of nerve cells that have been damaged. Together, these actions may prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit happening.

How has it been studied?

The effects of Vimpat were first tested in experimental models before being studied in humans.

The effectiveness of Vimpat taken by mouth has been compared with that of placebo (a dummy treatment) in three main studies involving a total of 1,308 patients. Patients added Vimpat at a dose of 200 mg, 400 mg or 600 mg a day, or placebo to their existing treatment of up to three other anti-epileptic medicines. The main measure of effectiveness was the number of patients whose number of seizures was at least halved after 12 weeks of treatment with a stable dose.
Two additional studies looked at the appropriate duration of the infusion for Vimpat solution and compared its safety with that of placebo infusions in a total of 199 patients.

What benefits has it shown during the studies?

Vimpat, at doses of 200 or 400 mg a day, was more effective than placebo in reducing the number of seizures. Looking at the results of the three main studies taken together, 34% of the patients adding Vimpat 200 mg/day and 40% of the patients adding Vimpat 400 mg/day to their existing treatment achieved at least a 50% reduction in the number of seizures. This was compared with 23% of the patients adding placebo. The 600-mg dose was as effective as the 400-mg dose, but it had more side effects.

What is the risk associated?

The most common side effects with Vimpat (seen in more than 1 patient in 10) are dizziness, headache, diplopia (double vision) and nausea (feeling sick). For the full list of all side effects reported with Vimpat, see the Package Leaflet.
Vimpat should not be used in people who may be hypersensitive (allergic) to lacosamide or any of the other ingredients, or who have second or third degree AV block (a type of heart rhythm disorder). Vimpat tablets must not be used in people who are hypersensitive to peanut or soya.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Vimpat?s benefits are greater than its risks when used as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. The Committee recommended that Vimpat be given marketing authorisation.

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