Zebinix Novel Treatment Also Demonstrated Significant Improvement by x29Gd4

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 Zebinix Novel Treatment Also
Demonstrated Significant Improvement
in Quality of Life and Reduction in
Depressive Symptoms

Zebinix(TM) is a novel voltage-gated sodium channel blocker
that has been designed to reduce the frequency of partial-
onset seizures when used in combination with other anti-
epileptic drugs.

This treatment has the potential to offer a new therapeutic
option for patients who continue to suffer partial seizures
despite receiving other anti-epileptic agents, with the
potential for additional benefits in terms of improvements in
quality of life and depressive symptoms.(2,3,4,5,6,7)

Positive data from three phase III studies presented at the
8th European Congress of Epileptology, Berlin, Germany,
demonstrated that Zebinix(TM) (1) (eslicarbazepine acetate),
a novel once daily anti-epileptic agent, significantly reduced
the frequency of partial seizures in patients with refractory
partial epilepsy, in combination with other anti-epileptic
agents.(2,3,4)

Zebinix(TM) is one of the proposed EU trade names for
eslicarbazepine acetate.

In addition, treatment with Zebinix(TM) also significantly
improved patient quality of life, reduced depressive
symptoms and demonstrated sustained reduction in partial
seizure frequency during a one-year open label period.(5,6,7)

"When assessing the potential of anti-epileptic agents it is as
important to consider the implications on the quality of a
patient's day-to-day life, as well as effective seizure control,"
said Professor E. Ben-Menachem, University of Goteborg,
Sweden. "In addition to sustained reductions in seizure
frequency, Zebinix(TM) also demonstrated a significant
improvement in patient quality of life and reduction in
depressive symptoms."
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Professor Christian Elger, Director and Head of the
Department of Epileptology at the University of Bonn,
Germany, added "these data suggest that Zebinix(TM) may
become an important treatment option for patients whose
seizures are not adequately controlled with existing anti-
epileptic agents."

Epilepsy is one of the most common neurological diseases
affecting almost one in 100 people.(8) Treatment of partial
seizures, the most common type of epilepsy, presents a
constant challenge with over half of patients not achieving
adequate seizure control with current anti-epileptic drugs.(9)

Zebinix(TM), a new anti-epileptic drug that selectively
inhibits the rapid firing nerve cells that cause seizures, has
been developed to address the need for a new anti-epileptic
agent that offers a reduction in seizure frequency combined
with a favourable tolerability profile. Zebinix(TM) is currently
under review by the EMEA (European Medicines Agency) for
the treatment of partial-onset seizures with or without
secondary generalisation in combination with other anti-
epileptic drugs. A US NDA (New Drug Application) is expected
later in 2008 or early 2009.

About the trials

The three phase III, multi-centre, randomised, placebo
controlled trials involved more than 1,000 patients from 23
countries. Patients had a history of at least four partial
seizures per month despite treatment with up to three
concomitant anti-epileptic drugs.(2,3,4)

During the trials, patients were randomised to
eslicarbazepine acetate or placebo and after a 2-week
titration period, were assessed over a 12 week maintenance
period, with continued follow-up over a one year open-label
period.(2,3,4,7)

Efficacy

Over the 12 week maintenance period, Zebinix(TM) 800mg
and 1200mg reduced seizure frequency by over one third,
and was significantly more effective than placebo. This
significant decrease in seizure frequency was sustained over
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the one-year open label treatment period and was consistent
regardless of baseline therapy..(2,3,4) 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 that ranged between 32%
and 43% across all three phase III trials. (2,3,4)

Tolerability

The safety profile of Zebinix(TM) was favourable. The
majority of treatment related adverse events were mild or
moderate in severity and after 6 weeks, no relevant
differences in the incidence of adverse events were apparent
between patients treated with eslicarbazepine acetate and
patients treated with placebo. In patients treated with
Zebinix(TM) the incidence of CNS side effects was low.
(2,3,4)

Quality of life and depressive symptoms

The effect of Zebinix(TM) on quality of life was analysed
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:5

- 16 per cent mean relative improvement in overall quality of
life (p<0.0001).

- 51 per cent improvement in worry about seizures
(p<0.0001)

- 41 per cent improvement in social function (p<0.001)

Improvement in depressive symptoms was also measured
using the Montgomery Asberg Depression Rating Scale
(MADRS). Zebinix(TM) demonstrated a significant
improvement in depressive mood and symptoms from
baseline (p<0.0001).(6)

About partial seizures and their treatment

Epilepsy is one of the most common neurological diseases,
affecting almost 1 in 100 people.(8) Treatment of partial
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seizures, the most common type of epilepsy, presents a
constant challenge - up to 58% of patients with partial
seizures do not achieve seizure control with current
antiepileptic drugs.(9)

Furthermore, adverse events, such as dizziness and
somnolence, are highly prevalent with existing anti-epileptic
agents and may affect as many as 97% of patients.(10)
Hence, there is a need for new anti-epileptic agents that offer
effective reduction in seizure frequency combined with a
favourable safety profile.

Epilepsy is characterised by abnormal firing of impulses from
nerve cells in the brain. In partial-onset epilepsy, these
bursts of electrical activity are initially focused in specific
areas of the brain, but may become more generalised; the
symptoms vary according to the affected areas. Nerve
impulses are triggered via voltage-gated sodium channels in
the nerve cell membrane.

								
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