Zebinix a New Anti-epileptic Drug That Offers Hope to Epilepsy Sufferers Major Phase III Study Data Released
LISBON, Portugal, June 19, 2008--Positive results from three Phase III studies of the new anti-epileptic drug ZebinixTM (eslicarbazepine acetate) were presented at the 9th Eilat Conference on New Anti-epileptic Drugs. These major studies, following over 1000 patients with refractory partial epilepsy treated with once-daily ZebinixTM in combination with other existing anti-epileptic agents demonstrated a significant reduction in the frequency of partial seizures.
The studies were used to support a European regulatory filing in March 2008. A US NDA (New Drug Application) is expected later in 2008 or early 2009.
ZebinixTM is under review by EMEA for the treatment of partial-onset seizures with or without secondary generalisation in combination with other anti-epileptic drugs.
ZebinixTM is a new anti-epileptic drug that selectively inhibits the rapid firing nerve cells that cause seizures and is the first ever drug to be developed by a Portuguese company, BIAL. ZebinixTM treatment produced a marked and sustained improvement in the condition of patients with epilepsy who were resistant to their current therapy.
Presenting the data, Professor E. Ben-Menachem, University of Goteborg
(Sweden) stated, "ZebinixTM once daily is a novel AED (Anti-Epileptic Drug) that offers added control to patients with partial epilepsy." Patients enrolled in the three large studies had a history of at least four partial seizures per month despite treatment with up to three concomitant anti-epileptic drugs.
ZebinixTM once-daily at doses of 800 mg and 1200 mg was significantly more effective than placebo in reducing seizure frequency over the 12-week maintenance period. Furthermore, ZebinixTM demonstrated marked and sustained reduction in seizures over an open-label one-year period.
Importantly, there were also significant improvements in health-related quality of life.
The safety profile of ZebinixTM was favourable, with the majority of patients able to continue with their medication due to the low rate of side effects particularly neuro-psychiatric side effects.
About the studies
The three large multi-centre, Phase III randomised, placebo-controlled trials involved 1049 patients aged 18 or over from 23 countries. Patients were randomised to ZebinixTM or placebo and then were followed up in an open-label study for one year.
In the intent-to-treat population (i.e. all patients in the study) there was a 35.4% relative reduction in seizure frequency over the 12-week maintenance period for the 800 mg once daily dosage regimen (p=0.0002) and a 38.8% reduction for the 1200 mg once daily dosage regimen (p=0.0001) compared with placebo. Furthermore, 36.3% of patients receiving 800 mg daily and 43.5% of patients receiving 1200 mg daily experienced a 50% or greater reduction in seizure frequency over the 12-week maintenance period (p=0.0001 and p<0.0001, respectively). Moreover, efficacy was sustained over the long-term.
About partial seizures and their treatment Epilepsy is one of the most common neurological diseases, affecting almost 1 in 100 people. Treatment of partial 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 .
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 . 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.
ZebinixTM is the new drug that selectively blocks these nerve cells to prevent seizures.
ZebinixTM 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 offers 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.
ZebinixTM is under review by EMEA (European Medicines Evaluation Agency) for the treatment of partial-onset seizures with or without secondary generalisation in combination with other anti-epileptic drugs.
Founded in 1924, BIAL is an international pharmaceuticals group with products available in nearly 30 countries over four continents. BIAL group is the largest Portuguese pharmaceutical company and is based in S. Mamede do Coronado, Portugal.
BIAL is strongly committed to therapeutic innovation on research and development every year. This commitment has been recognised in the group's recent integration into the EFPIA (European Federation of Pharmaceutical Industries and Associations), which is dedicated to encouraging research and the development of new therapeutic options.
Key research areas for BIAL are the central nervous system, the cardiovascular system and allergology. BIAL¹s dedication to research is further demonstrated by the research grants and awards offered by the BIAL Foundation.
BIAL (Head Office)
Posted: June 2008