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New Data Support Long-term Use of Antiepileptic Drug Vimpat(R) (Lacosamide) (C-V)
Date:12/7/2009

l program for Vimpat® has yielded safety and efficacy data totaling almost 3,000 patient years of exposure," said Dr. Jacqueline French, Director of the Clinical Trials Consortium at the Comprehensive Epilepsy Center at New York University Langone Medical Center.

Vimpat® was launched in the U.S. in May 2009 as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are 17 years and older, and is available as oral tablets and as an intravenous (IV) infusion to allow for consistent treatment in a hospital setting. In Europe, Vimpat® (film-coated tablets, syrup, and solution for infusion) is approved as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy, aged 16 years and older. Vimpat® has a novel mechanism of action that is different from all currently available AEDs, although the precise mechanism by which Vimpat® exerts its antiepileptic effect in humans is not yet clear.

Summary of Vimpat® Data Presented at 2009 AES Annual Meeting

Abstract: Long-term Efficacy of Lacosamide for Partial-Onset Seizures: An Interim Evaluation of Completer Cohorts Exposed to Lacosamide for up to 36 Months

This analysis of phase II/III open-label extension trials demonstrated that lacosamide produced long-term, sustained efficacy in patients with partial-onset seizures who completed 6, 12, 18, 24, 30, or 36 months of treatment. Researchers noted that given the study's "nested cohort" design, with each cohort including patients remaining from the shorter-duration cohort, the expected attrition of non-responders is accounted for, and efficacy findings reflect real-world use.

  • The reduction in seizure frequency associated with lacosamide was sustained across all duration cohorts, as was the proportion of responders - patient
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SOURCE UCB
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