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