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Phase III Data Demonstrate Efficacy and Tolerability of Carisbamate as an Adjunctive Therapy for Partial Onset Seizures
Date:12/6/2008

SEATTLE, Dec. 6 /PRNewswire/ -- Phase III data on carisbamate, an investigational compound recently filed with the FDA for the adjunctive treatment of partial onset seizures (POS) in patients 16 years of age and older, was presented today during the poster sessions of the 32nd Annual Meeting of the American Epilepsy Society.

Results from two identical placebo-controlled clinical trials investigating the efficacy, safety and tolerability of carisbamate as an adjunctive treatment for patients with POS were presented along with results of a pharmacokinetic/ pharmacodynamic (PK/PD) analysis.

"Although several new antiepileptic drugs have become available in the past decade, there is still unmet patient need. Long-term treatment success is not only determined by seizure control, but equally by tolerability, which is reflected by a patient's ability to remain on medication," said Michael Sperling, M.D. of Thomas Jefferson University and an investigator in the trials. "The carisbamate data presented at AES not only demonstrate benefit of carisbamate in reducing seizure frequency in some patients with partial onset seizures, but also shows an impressive tolerability profile."

Adjunctive Therapy of Partial Onset Seizures in Adults

Two identically designed, randomized, double blind, placebo-controlled global studies were presented in the first poster. Patients with an established diagnosis of uncontrolled POS for one year or more were eligible. The subjects remained on stable doses of a prescribed antiepileptic drug (AED) for 8-weeks (baseline phase) and were then randomized to receive carisbamate 200 mg/day, carisbamate 400 mg/day, or placebo on top of these existing AEDs. Efficacy endpoints were median percent reduction in seizure frequency in the double blind phase compared to the baseline phase, and the proportion of patients with 50% or greater reduction in POS frequency during
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SOURCE Ortho-McNeil Neurologics
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