Beyond Seizure Control in the Treatment of Epilepsy With New Anti-Epileptic Drug, Z...(wasconsistent regardless of baseline the...)

Date:12/8/2008

was consistent regardless of baseline therapy.(2)-(11) Similar positive findings were observed in the responder rate ((greater than or equal to)50% decrease in seizure frequency) for Zebinix(TM) 800mg and 1200mg once-daily that ranged between 32% and 43% across all three phase III trials.(5)-(7)

Tolerability

The safety profile of Zebinix(TM) was favourable. The majority of treatment related adverse events were mild or moderate in intensity. After 6 weeks, the incidence of new CNS side effects was low in patients treated with Zebinix(TM).(2)-(11) These results parallel findings from earlier Phase 2.(16)

Quality of life and depressive symptoms

The effect of Zebinix(TM) 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.(2)-(4)

Improvement in depressive symptoms was also measured using the Montgomery Asberg Depression Rating Scale (MADRS). During long-term, open-label therapy, Zebinix(TM) 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.(2)-(4)

Notes to Editors

About partial seizures and their treatment

Epilepsy is one of the most common neurological diseases, affecting almost 1 in 100 people.(12) Treatment of partial seizures, the most common type of epilepsy, presents a constant challenge - up to two-thirds of
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