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Epilepsia Study Demonstrates New Add-on Antiepileptic Drug Vimpat(R) (lacosamide) Significantly Reduces Partial-Onset Seizures in Adults With Epilepsy
Date:1/27/2009

- Vimpat(R) demonstrated greater seizure reduction and improved seizure freedom versus placebo when added to first and second-generation antiepileptic drugs (AEDs)

- Phase III study supports recent U.S. FDA and European Commission approvals of Vimpat(R)

ATLANTA, Jan. 27 /PRNewswire-FirstCall/ -- The new antiepileptic drug Vimpat(R) (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(R) 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(R) 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 peopl
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SOURCE UCB
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