Lacosamide UCB

The European Medicines Agency decided that Lacosamide UCB, used alone or added to other epilepsy medicines, had been shown to be effective in the treatment of partial-onset and tonic clonic seizures. Taking its side effects into account, the Agency decided that Lacosamide UCB’s benefits are greater than its risks and it can be authorised for use in the EU.

The most common side effects with Lacosamide UCB (which may affect more than 1 in 10 people) are dizziness, headache, diplopia (double vision) and nausea (feeling sick). The risk of side effects affecting the nervous system such as dizziness may be higher after a high first dose and dizziness was the most common reason for stopping treatment.

Lacosamide UCB must not be used in people who have second- or third-degree AV block (a type of heart rhythm disorder). For the full list of side effects and restrictions of Lacosamide UCB, see the package leaflet.

The medicine can only be obtained with a prescription and is available as tablets, as a syrup and as a solution for infusion (drip) into a vein. Lacosamide UCB should be taken twice a day; the dosage depends on the patient’s weight and age, as well as whether Lacosamide UCB is used alone or with other epilepsy medicines.

Lacosamide UCB infusion can be used to begin treatment. It can also be used in patients who are temporarily unable to take the medicine by mouth.

For more information about using Lacosamide UCB, see the package leaflet or contact your doctor or pharmacist.

The active substance in Lacosamide UCB, lacosamide, is an epilepsy 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. This action may prevent abnormal electrical activity in the brain, reducing the chance of an epileptic fit.

Partial-onset seizures

Lacosamide UCB was effective at reducing partial-onset seizures in three main studies involving a total of 1,308 patients aged 16 years and above also taking other epilepsy medicines. Patients were given Lacosamide UCB by mouth at a dose of 200 mg, 400 mg or 600 mg a day, or placebo (a dummy treatment) in addition to their existing epilepsy medicines. Taking the results of the three main studies together, 34% of the patients taking Lacosamide UCB 200 mg a day and 40% of those taking Lacosamide UCB 400 mg a day with their existing treatment had a reduction in their seizures by at least half after 12 weeks of treatment. This compared with 23% of the patients receiving placebo. The 600-mg dose was as effective as the 400-mg dose, but it had more side effects.

A fourth study involving 888 recently diagnosed patients found that Lacosamide UCB, used on its own at a dose of 200 mg to 600 mg a day, was at least as effective as carbamazepine, another epilepsy medicine. The main measure of effectiveness was the proportion of patients who did not have a partial-onset seizure for at least 6 months after reaching a stable dose. This was found to be 90% in those taking Lacosamide UCB and 91% in those taking carbamazepine. Around 78% of Lacosamide UCB-treated and 83% of carbamazepine-treated patients did not have a seizure for 12 months.

Two additional studies looked at the appropriate duration of the infusion for Lacosamide UCB 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 starting treatment with doses of 200 mg Lacosamide UCB by infusion, followed by regular doses taken by mouth, can be applied safely and that adequate levels in the body are achieved. The company also provided data to support dosing of Lacosamide UCB in children from 24 years of age and supportive results from studies of the safety of Lacosamide UCB in this population.

Tonic-clonic seizures

A further study involving 242 patients from 4 years with idiopathic generalised epilepsy compared Lacosamide UCB with placebo, both used with other epilepsy medicines. The study showed that Vimpat lowered the risk of having a tonic-clonic seizure: after 24 weeks of treatment, around 31% of patients taking Vimpat were free from seizures compared with around 17% of patients receiving placebo.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lacosamide UCB have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Lacosamide UCB are continuously monitored. Side effects reported with Lacosamide UCB are carefully evaluated and any necessary action taken to protect patients.

Lacosamide UCB received a marketing authorisation valid throughout the EU on 26 August 2019