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Zonegran study could pave way for paediatric licence

Published on 02/09/11 at 08:57am

Eisai’s epilepsy drug Zonegran has been found more effective than placebo in children with the neurological condition who have seizures.

The phase III CATZ study also showed Zonegran (zonisamide) was well-tolerated in paediatric patients treated with one or two other anti-epileptic drugs.

Licensed from Dainippon Sumitomo Pharma, Zonegran is currently used as adjunctive therapy in adults with such seizures, with or without secondary generalisation.

The preliminary findings presented at Rome’s Epilepsy Congress this week could open up a new patient group: of the estimated 50 million people worldwide who have epilepsy, 10.5 million are children under the age of 15.

Many children have to take more than one type of anti-epileptic to reduce seizures.

CATZ set out to assess adjunctive Zonegran in 207 patients aged six to 17 with partial-onset seizures who were on one or two anti-epileptics.

Primary endpoint was the proportion of responders after 12 weeks: 50.5% responded positively versus 31% with placebo, with safety and tolerability similar in both.

Decreased appetite, weight loss, somnolence, vomiting and diarrhoea were among the reported side effects.

Zonegran is one of a trio of epilepsy drugs which the Japanese firm has on the European market: Zebinix (eslicarbazepine acetate) has the same indication, while Inovelon (rufinamide) is an add-on for seizures associated with Lennox-Gastaut Syndrome.

But earlier this year, the FDA refused to file Eisai’s anti-epileptic perampanel, saying it needs more information for the treatment.

In June, GlaxoSmithKline and Valeant’s Potiga (ezogabine) was approved by the US regulator, but it will require further review before it can be launched.

Known as Trobalt (retigabine) outside the US, it was approved in March as an adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above.

Despite this success, patent expiries such as GlaxoSmithKline’s blockbuster Lamictal and Johnson & Johnson’s Topomax (due to go next year) are set to make the epilepsy market a tricky one for new entrants.

Adam Hill

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