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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/710648/2012

EMEA/H/C/000863

EPAR summary for the public

Vimpat

lacosamide

This is a summary of the European public assessment report (EPAR) for Vimpat. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Vimpat.

What is Vimpat?

Vimpat is a medicine containing the active substance lacosamide. It is available as tablets (50 mg;

100 mg; 150 mg; 200 mg), as a syrup (10 mg/ml) and as a solution for infusion (drip into a vein,

10 mg/ml).

What is Vimpat 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 Vimpat used?

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.

If the doctor decides that a faster effect is needed, treatment with Vimpat may be started with an initial higher dose (loading dose) of 200 mg, followed, approximately 12 hours later, by a maintenance

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dose of 100 mg twice a day. The dose may then be further increased every week to the maximum dose depending on the patient's response.

Vimpat infusion can be used to initiate treatment. It can also be used in patients who are temporarily unable to take the tablets or syrup.

If treatment with Vimpat has to be stopped, the dose should be gradually reduced. Lower doses should be used in patients with severely reduced kidney function.

How does Vimpat 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 Vimpat been studied?

Vimpat taken by mouth has been compared with 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. An additional study in 118 patients was carried out to test that loading doses of 200 mg Vimpat by infusion, followed by maintenance doses taken by mouth, can be applied safely and that adequate levels in the body are achieved.

What benefit has Vimpat 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 with Vimpat?

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). Side effects affecting the nervous system such as dizziness may be higher after a loading dose. For the full list of all side effects reported with Vimpat, see the package leaflet.

Vimpat must not be used in people who are 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).

Why has Vimpat been approved?

The CHMP decided that Vimpat's benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Vimpat

The European Commission granted a marketing authorisation valid throughout the European Union for Vimpat on 29 August 2008.

The full EPAR for Vimpat can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Vimpat read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 11-2012.

Vimpat

EMA/710648/2012

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