New data on the novel anti-epileptic drug (AED) Zonegran® (zonisamide) is presented today at the 10th European Congress on Epileptology (ECE) in London. Since July 2012, zonisamide has been licensed in the EU as a monotherapy for newly diagnosed-adults who have partial seizures, with and without secondary generalisations, and also as an adjunctive therapy.
Certain patient population may require additional studies to demonstrate efficacy and safety compared to the general adult population. In elderly patients, caution maybe required when making dose recommendations. Data from elderly patients from the pivotal phase III studies were examined to see if differences could be determined in respect to the use of zonisamide. Findings from the studies showed that the safety and efficacy of zonisamide were similar to those reported in the general adult population. In addition, paediatric patients sometimes require specific dosing regimens, and additional safety and tolerability evidence beyond that available for adult populations. Zonisamide, which does not have paediatric licence, is currently under investigation in a paediatric patient population (6-17 years) for adjunctive use in partial-onset seizures in Europe.
The following Eisai posters are being presented at this year's ECE:
Poster Session Medical therapy and Zonisamide pharmacology 2 Abstract p177 Monday October 1 Giorgi L, Chouette I 12:39-12:48 Poster Session Medical therapy and pharmacology 3 Zonisamide Monday October 1 Abstract p178 14:00 Giorgi L, Chouette I Poster Session Medical therapy and pharmacology 2 Zonisamide Monday October 1 Abstract p166 12:30-12:39 Rosati A, Segieth L, Giorgi L, Guerrini R Poster Session Antiepileptic drugs Zonisamide Monday October 1 Abstract p019 11:30 Hall G Trinka E, Segieth L, Giorgi L Poster Session Medical therapy and pharmacology 10 Zonisamide Wednesday October 3 Abstract p663 12:57-13:06 Baulac M, Rugg-Gunn F, Chouette I
The development of zonisamide underscores Eisai's human health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well-being of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families. Eisai is proud to currently market more epilepsy products in EMEA than any other company.
About Zonegran (zonisamide)
Zonisamide is licensed in Europe as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy. In addition, zonisamide is also indicated as adjunctive therapy in the treatment of partial seizures (with or without generalisation) in adults with epilepsy. It has a broad spectrum of anti-epileptic modes of action and has no appreciable effects on steady-state plasma concentrations of other AEDs, such as phenytoin, carbamazepine and valproate.
Zonisamide is available in 25mg, 50mg, and 100mg capsule strengths. The recommended initial daily dose for adjunctive use is 50mg in two divided doses. After one week the dose may be increased to 100 mg daily and thereafter the dose may be increased at weekly intervals, in increments of up to 100 mg.
For more information please visit: http://www.zonegran.eu
Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people in Europe. There are an estimated six million people living with epilepsy in Europe, and an estimated 50 million people with the condition worldwide. Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity causing seizures. Seizures can vary in severity, from brief lapses of attention or jerking of muscles, to severe and prolonged convulsions. Depending on the seizure type, seizures may be limited to one part of the body, or may involve the whole body. Seizures can also vary in frequency from less than one per year, to several per day. Epilepsy has many possible causes but often the cause is unknown.
About Eisai Europe in Epilepsy:
Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with epilepsy. The development of AEDs is a major strategic area for Eisai in Europe, the Middle East, Africa and Russia (EMEA).
In the EMEA region, Eisai currently has four marketed treatments including:
- Zonegran® (zonisamide) as monotherapy and adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zonegran is under license from the originator Dainippon Sumitomo Pharma)
- Zebinix® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL)
- Inovelon® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years
- Fycompa® (perampanel) for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older
Eisai recently expanded their UK Hatfield commercial, research and manufacturing facility which now supports the company's growing EMEA business.
Eisai concentrates its R&D activities in three key areas:
- Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight loss Fycompa® (perampanel) for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older
- Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc.
- Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, inflammatory bowel disease
With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 11,000 people worldwide. In Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Slovakia, the Netherlands, Belgium, Luxembourg, the Middle East and Russia.
For further information please visit our web site http://www.eisai.com.
1. Zonegran SPChttp://www.medicines.org.uk/emc/medicine/16240/SPC/
2. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007: 48(12) 2224 - 2233.
3. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe.http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed 10 April 2012].
Date of preparation: September 2012
Job code: Zonegran-UK2456
SOURCE Eisai Europe Limited