Eisai Europe has launched a child-friendly drinkable medicine to treat seizures associated with Lennox-Gastaut Syndrome (LGS), a rare form of epilepsy.

Inovelon (rufinamide) is indicated as an adjunctive therapy for seizures caused by Lennox-Gastaut syndrome in patients aged four and older.

The orange-flavoured liquid formulation is designed to aid treatment in children whose condition means they have difficulty in swallowing tablets.

LGS affects up to three in every 10,000 children in Europe, accounting for 10% of childhood epilepsy cases.

Medication compliance is crucial to LGS management, as the disease causes frequent seizures associated with mental retardation and regression.

Inovelon, which regulates electrical charges in the brain, was approved in tablet form for LGS treatment in 2007. The drinkable version gained EMA approval in November 2011.

The UK and the Netherlands follow Germany in the European launch of the liquid Inovelon, with other EU countries to follow this year.

Helen Cross, Head of Neuroscience Unit at the UCL Institute of Child Health, London, commented: “Many children (and in fact adults), particularly those with complex epilepsy and associated neurodevelopmental problems such as LGS, experience difficulties with swallowing tablets. A suspension formulation of new and targeted medication is always welcome therefore to widen the availability to the full population of affected individuals.”

“The availability of the oral suspension formulation will hopefully make treatment easier for children and young people with LGS,” said Mike Bee, Eisai Europe’s Epilepsy Business Unit Director for EU North. “Our efforts are now focused to ensure that this new formulation is made available at centres throughout the UK as soon as possible.”

The development of anti-epileptic drugs is a major strategic focus for Eisai in the European market, Inovelon being one of three medications it currently sells in this therapy area.

The CHMP has recommended that Vimpat syrup should no longer be marketed after a quality defect in certain batches lead to the uneven distribution of the active substance lacosamide.

The decision follows a review of the 15mg/ml medicine which concluded the benefit no longer outweighs the risk and that patients may receive either too much or too little of the substance.

The EMA says doctors should contact patients currently using the syrup as soon as possible and switch their prescription to Vimpat film-coated tablets where possible.

For patients unable to take the tablets, the EMA says it may be possible to obtain the US-approved Vimpat liquid formation – which does not have a quality defect. The liquid formation is currently under review by the CHMP after a marketing authorisation application was submitted in August 2011.

The review began in July this year after the EMA was informed by the marketing authorisation holder that a ‘flake-like’ precipitate had been observed in bottles of the medication.

Further analysis then showed that lacosamide was not evenly distributed and may lead to patients receiving varying doses of the substance. Although no cases of adverse reactions were noted, the CHMP agreed to a proposal from the application holder to recall the product from the supply chain as a precautionary measure.

Vimpat has been authorised in the European Union since 2008 and is used to treat epileptic seizures as an add-on treatment to other antiepileptic medicines in patients aged 16 years and older.