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Title: Lacosamide Approved in Europe for Partial-Onset Epilepsy
URL: http://www.pslgroup.com/dg/22A7EA.htm
Doctor's Guide
September 3, 2008

BRUSSELS, Belgium -- September 3, 2008 -- The European Commission (EC) has approved lacosamide (Vimpat) as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.

"[Lacosamide] offers new hope for improved seizure control in adult patients with partial onset seizures … [it] should be considered a valuable treatment option for adult patients with partial-onset seizures who need additional seizure control," said trial investigator Elinor Ben-Menachem, Department of Clinical Neuroscience, Göteborg University, Göteborg, Sweden.

The approval is based on data from 3 multicentre, randomised, placebo-controlled clinical trials that evaluated the efficacy and safety of lacosamide adjunctive treatment in over 1,300 patients aged 16 years and older with partial-onset seizures that were not adequately controlled with between 1 to 3 concomitant antiepileptic drugs (AED) and with or without additional vagus nerve stimulation.

Patients entering these trials were experiencing on average 10 to 15 seizures per month and most patients (84%) were uncontrolled on 2 to 3 AEDs.

In clinical trials lacosamide improved seizure control when added to a wide range of first and second generation AEDs. Pooled analysis shows that treatment with lacosamide 200 mg/day and 400 mg/day reduced seizures by half in 34% and 40% of patients with partial-onset seizures, compared with 23% in the placebo group.

Lacosamide was generally well tolerated with the most common adverse events (>=10%) reported in these trials including dizziness, headache, nausea, and diplopia.

In a long-term study, patients treated with lacosamide achieved sustained reductions in partial-onset seizures. Of 370 patients who took part in this open-label trial, 77% completed at least 12 months of treatment, 61% completed at least 24 months, and 56% completed at least 30 months of treatment.


SOURCE: UCB Group

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