New data from three abstracts on Eisai's epilepsy portfolio are to be presented at this year's World Congress of Neurology (WCN) in Vienna. The abstracts include a long-term safety and efficacy clinical study of Zonegran (zonisamide) monotherapy,[1] and two real-life safety and efficacy studies of Fycompa (perampanel)[2] and Zebinix (eslicarbazepine acetate).[3][*]
The first abstract to be presented at the WCN on Sunday 22 September shows that zonisamide monotherapy demonstrated favourable long-term safety and maintenance of efficacy in the study group (n=295), with no new or unexpected safety findings.[1] This double-blind, extension study looked at the long-term safety and maintenance of efficacy of zonisamide versus carbamazepine monotherapy for partial seizures in adults with newly diagnosed epilepsy. The incidence of treatment-emergent adverse events (TEAEs) was similar for both zonisamide and carbamazepine (52.6% vs. 46.2%) as was the proportion of patients remaining seizure free for over 24 months (32.3% vs. 35.2%, intent to treat population).[1]
Zonisamide is an anti-epileptic drug (AED) with multiple mechanisms of action and a structure which is chemically unrelated to any other AED.[4] In July 2012, zonisamide received EMA approval as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy.[4] Since March 2005, zonisamide has been used as an adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults.[4]
Further data to be presented on Wednesday 25 September for eslicarbazepine acetate show nearly 20% (19.8%) of patients achieved seizure freedom, of which 65% had 0-1 previous AED exposures. Over 50% (52%) experienced a 50% or greater seizure frequency reduction.[3] This study focused on the safety and efficacy of eslicarbazepine acetate in everyday clinical practice. Data from the study were gathered in a retrospective, multicentre audit across seven sites in the United Kingdom between 2009 and 2013 (n=202). Adverse events reported were consistent with eslicarbazepine acetate's known safety profile.[3]
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[*]. Zebinix is under license from BIAL
Eslicarbazepine acetate is a third generation sodium channel blocker that selectively targets slow inactivated sodium channels. It is indicated as adjunctive therapy for adults with partial onset seizures, with or without secondary generalisation, and has an oral, once-daily dose regimen.[5]
Additional data to be presented on Wednesday 25 September demonstrate that perampanel is well tolerated and leads to a significant improvement in seizure control for 22% of patients (75-100% reduction in seizure frequency).[2] The study retrospectively examined data from 58 people who have received perampanel since 2009 and looks specifically at treatment response and adverse effects. The most common adverse effects reported include vertigo (31%), fatigue (14%) and nausea (7%). Adverse effects, in particular vertigo, can be avoided by taking perampanel immediately before bedtime or by dose reduction.[2],[6]
Perampanel is the first and only licensed AED to selectively target AMPA receptors postsynaptically, which play an important role in the spread of epileptic seizures.[6] Perampanel can be given once-daily and is indicated as adjunctive therapy for adolescents and adults with partial onset seizures, with or without secondary generalisation.[6]
"We are delighted to present new data on our key epilepsy products at this year's WCN and are committed to conducting long-term and real-life studies such as these to increase our knowledge of these products and help people with epilepsy across Europe," commented Jenny Brown, Strategic Alliance & Marketing Director, Eisai EMEA. "The results demonstrate the strength and breadth of our epilepsy portfolio, which offers a range of once-daily treatment options for people with partial epilepsy, whether newly diagnosed or for those who require multiple anti-epileptic agents."