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Published on 16 January 2008

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FDA accepts levetiracetam filing

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The FDA has accepted for filing a new drug application for the use of levetiracetam (Keppra XRâ„¢) extended-release tablets in adjunctive treatment of partial-onset seizures in adults with epilepsy.

Keppra is made by Belgian-based UCB Group.

UCB global head of development Dr Iris Loew-Friedrich commented: “There is an ongoing need for new antiepileptic drug options without the limitations of twice-daily dosing.

“Epilepsy therapies with more convenient dosing schedules may help encourage greater patient compliance, which is important to effective seizure control.”

She said the filing was supported by a phase III multicentre, randomised, double-blind, placebo-controlled study evaluating the efficacy, safety and tolerability of extended-release tablets (2 x 500mg) once-daily as adjunctive therapy in 158 refractory epilepsy patients, 12�”70 years of age, with partial-onset seizures.

The study met its primary endpoint for seizure reduction over placebo during the treatment period (p=0.038).

The median per cent reduction of partial-onset seizures in the extended-release levetiracetam group was 46.1% compared to 33.4% with placebo during the 12-week treatment period.

Additionally, 24% of patients randomised to the extended-release levetiracetam group had seizure frequency per week reduced by 75�”100%, compared with 11.4% of patients in the placebo group.

In the extended-release levetiracetam group 10.1% of patients had 100% reduction in partial-onset seizures and 8.9% were free from any type of seizure over the treatment period, compared to 2.5% and 1.3% in the placebo group, respectively.

The study also found that extended-release levetiracetam tablets were generally well tolerated.

The most common reported adverse events that occurred more frequently in the extended-release levetiracetam group were somnolence, influenza, nausea, nasopharyngitis, irritability and dizziness.

UCB Group

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