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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

the 12-week double blind phase.

Carisbamate was well tolerated, with minimal central nervous system-related adverse events and a low discontinuation rate. The most common adverse events were dizziness and somnolence. The rate of treatment-emergent adverse events resulting in discontinuation from carisbamate was 3% in each study. Results showed that treatment with carisbamate 400 mg resulted in significant improvement in both efficacy measures compared with placebo in study 1, but not in study 2. Carisbamate 200 mg/day did not differ from placebo in either study. In both studies, concomitant use of enzyme-inducing AEDs lowered plasma levels of carisbamate by up to 44% (40% in study 1 and 44% in study 2). As a result, there were greater percentage reductions in POS frequency among patients treated with carisbamate who received concomitant non-enzyme inducing AEDs.

PK/PD Modeling of the Effect of Carisbamate

A second poster showed results of an analysis of three studies, which evaluated the efficacy of carisbamate, using a PK/PD model to predict the effect of carisbamate over a dose range of 400 mg/day to 1200 mg/day. The relationship between percent reduction of POS from baseline and steady state trough concentration was investigated.

The model showed that seizure reduction increased with greater drug exposure levels. Carisbamate pharmacokinetics were influenced by the co-administration of enzyme-inducing AEDs, which reduced carisbamate exposure by about 33-40%. In all three studies separately, a statistically significant positive relationship between seizure rate reduction and steady state trough concentrations was found. The PK/PD simulations predicted that treatment with 400 mg/day provides clinically meaningful effects for all subjects, with further increase in effect with dosages of 800 mg and 1200 mg/day for patients on enzyme-inducing or non-enzyme inducing AEDs.

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SOURCE Ortho-McNeil Neurologics
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