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Data Demonstrates Long-Term Reduction In Seizure Frequency With Novel Once Daily Anti-Epileptic Zebinix(R)
Date:6/28/2009

ure frequency was sustained over the one-year open label treatment period and was consistent regardless of baseline therapy.

Tolerability

The safety profile of ESL was favourable. The majority of treatment related adverse events were mild or moderate in intensity. After 6 weeks of treatment, there were no observed differences in the incidence of side effects between patients treated with ESL and the placebo group.

Quality of life and depressive symptoms

The effect of ESL on quality of life was assessed using the Quality of Life Epilepsy Inventory-31 (QOLIE-31) scale. There was a statistically and clinically significant improvement from baseline during long-term open-label therapy, including a mean relative improvement in overall quality of life (p<0.001 - p<0.01 across the three studies) and improvements in individual elements of the QOLIE-31 scale including seizure worry, emotional wellbeing, energy/fatigue, medication effects and social function(8).

Improvement in depressive symptoms was also measured using the Montgomery Asberg Depression Rating Scale (MADRS). During long-term, open-label therapy, ESL demonstrated a statistically significant improvement from baseline in the overall MADRS score (p<0.0001) and individual domains of the MADRS scale including pessimistic thoughts, concentration difficulties, apparent sadness and inner tension(8).

These data were presented at the 28th International Epilepsy Congress held in Budapest, 28 June 2009 - 2 July 2009, the 8th European Congress on Epileptology held in Berlin last September 2008 and at the Annual Meeting of the American Epilepsy Society (AES) in December 2008, Seattle, WA, USA.

About BIAL

Founded in 1924, BIAL is an international pharmaceutical group with products available in over 30 countries throughout four continents. BIAL is the largest Portuguese pharmaceutical com
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