New Study Demonstrates Efficacy of Zonegran® (Zonisamide) as Adjunctive Therapy in Children Being Treated for Partial Epilepsy

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Eisai Europe Limited

31 Aug, 2011, 12:21 GMT

HATFIELD, England, August 31, 2011 /PRNewswire/ --

Eisai today announced preliminary results from a new Phase III paediatrics study which showed that the anti-epilepsy treatment Zonegran® (zonisamide/ZNS) is more effective than placebo and well tolerated in paediatric patients with partial-onset seizures treated with one or two other anti-epileptic drugs.[1] The results of the CATZ study were presented for the first time during the 29th International Epilepsy Congress, taking place in Rome from 28 August until 1 September, 2011.

The double-blind, randomised, multicentre, placebo-controlled study set out to assess the efficacy and safety/tolerability of adjunctive zonisamide in 207 paediatric patients (6-17 years) with partial-onset seizures who were on one or two anti-epileptic drugs. The study's primary endpoint was the proportion of responders (≥50% seizure frequency reduction) after 12 weeks maintenance treatment. Safety/tolerability evaluation included assessment of treatment-emergent adverse events (TEAEs).[1]

Commenting on this new study, Professor Renzo Guerrini, Children's Hospital Anna Meyer, University of Florence, Italy said "There are a large proportion of children who do not get complete seizure control and have to take more than one type of anti-epileptic to reduce seizures. We know that zonisamide is already a successful add-on treatment and is also very effective in newly diagnosed adults with epilepsy.  I welcome these study results as they indicate that the paediatric population could stand to significantly benefit too."

The percentage of patients who completed the study was comparable between the zonisamide and placebo groups (86.9% patients on zonisamide and 90% patients on placebo). Results showed that significantly more patients responded positively to treatment with zonisamide (50.5%) versus treatment with placebo (31.0%).[1]

Safety and tolerability assessments showed that the overall incidence of TEAEs was similar for zonisamide (55.1%) versus placebo (50.0%). There were low rates of serious TEAEs in the zonisamide and placebo groups (3.7% vs 2.0%), and TEAEs leading to withdrawal from the study (0.9% vs 3.0%). TEAEs reported more frequently with zonisamide versus placebo were decreased appetite (6.5% vs 4.0%), decreased weight (4.7% vs 3.0%), somnolence (4.7% vs 2.0%), vomiting (3.7% vs 2.0%) and diarrhoea (3.7% vs 1.0%).[1]

Notes to Editors

About Zonegran® (zonisamide)

Zonisamide is licensed 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 anti-epileptic drugs, such as phenytoin, carbamazepine, and valproate.[2]

Zonisamide is available in 25mg, 50mg, and 100mg capsule strengths. The recommended initial daily dose 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 100mg.[2]

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world, affecting approximately 8 in 1,000 people in Europe.[3] There is an estimated six million people living with epilepsy in Europe[4] and estimated 50 million people worldwide,[5] 10.5 million of which are children under the age of 15.[6]

Epilepsy is characterised by abnormal firing of impulses from nerve cells in the brain causing seizures. Depending on the seizure type, seizures may be limited to one part of the body, or may be generalised to involve the whole body.

Patients may also experience abnormal sensations, altered behaviour or altered consciousness. Epilepsy is a disorder with many possible causes. Often the cause of epilepsy is unknown. However, anything that disturbs the normal pattern of neuron activity - from illness to brain damage to tumours, can lead to seizures.[7]

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 anti-epileptic drugs (AEDs) is a major strategic area for Eisai in the European market.

In Europe, Eisai currently has three marketed treatments including:

  • Zonegran® (zonisamide) as 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 adjunctive treatment, 4 years and older of seizures associated with Lennox-Gastaut Syndrome.

About Eisai

Eisai is one of the world's leading R&D-based pharmaceutical companies and has defined its corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc).

Eisai concentrates its R&D activities in three key areas:

  • Neuroscience, including: Alzheimer's disease, multiple sclerosis, neuropathic pain, epilepsy, depression
  • Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc and supportive cancer therapies; pain relief, nausea
  • Vascular/Immunological reaction including: acute coronary syndrome, atherothrombotic disease, severe sepsis, rheumatoid arthritis, psoriasis, Crohn's disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan, we employ 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, Hungary, Slovakia and the Netherlands.

For further information please visit our web site http://www.eisai.com

References

1. Rosati A, Pellacani P, Falchi M, Guerrini R.  Preliminary results from the CATZ Study: a phase III, double-blind, randomised, placebo-controlled trial to assess the efficacy and safety of adjunctive zonisamide in paediatric patients with partial-onset seizures. P870 Abstract#914  Presented at 29th International Epilepsy Congress, 28th August until 1st September, 2011, Rome

2. Eisai Ltd. Zonegran Summary of Product Characteristics [http://emc.medicines.org.uk ] (Last updated July 2011)

3. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007: 48(12) 2224-2233

4. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available from; http://www.ilae-epilepsy.org/Visitors/Documents/EUROReport160510.pdf (Accessed June 2011)

5. Epilepsy Society UK: http://www.epilepsysociety.org.uk/AboutEpilepsy/Whatisepilepsy/Epilepsy-didyouknow (Accessed June 2011)

6. Forsgren L. Epilepsy in Children. 2nd Ed London. Arnold, 2004. 21-25

7. Epilepsy Research UK. What is Epilepsy? Fact sheet. Available from URL: http://www.epilepsyresearch.org.uk/about_us/leaflets/lflt1.htm (Accessed June 2011)