Study: Adding Vimpat significantly reduces partial-onset seizures in adults wit...( Atlanta GA January 27 2009 press r...),Health

Atlanta, GA January 27, 2009 press release The new antiepileptic drug Vimpat (lacosamide) demonstrated significantly fewer seizures in adult partial-onset epilepsy patients whose seizures were inadequately controlled despite taking up to three other AEDs, according to a Phase III clinical study published online in Epilepsia.

In the study, seizure reduction was measured by:

Primary Endpoints

• The change in seizure frequency per 28 days from baseline to the maintenance period.
• The 50 percent responder rate, defined as the proportion of patients experiencing a 50 percent or greater reduction in partial seizure frequency per 28 days from the baseline to the maintenance period.

Secondary Endpoints -- Seizure freedom:

• The number and proportion of patients achieving seizure-free status throughout the maintenance period for patients completing the maintenance period.
• The proportion of seizure-free days during the maintenance period for patients entering the maintenance period.

Vimpat was recently approved by the U.S. Food and Drug Administration (FDA) for use as an add-on therapy for the treatment of partial-onset seizures in adult patients with epilepsy. Earlier this year, the European Commission approved Vimpat for the adjunctive treatment of partial-onset seizures with or without secondary generalization in adult patients with epilepsy.

"These results are particularly encouraging given the number of people with epilepsy who, despite current therapies, still face the challenge of living with uncontrolled seizures," said lead study author Professor Pter Halsz, MD, PhD, National Institute of Psychiatry and Neurology, Neurology Department, Budapest. "Vimpat showed significant efficacy versus placebo in a challenging clinical trial patient population."

In the study, 87 percent of patients were taking at least two AEDs and 37 percent were takin
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