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Keppra XR (levetiracetam) extended-release tablets significantly reduced partial onset seizure frequency when administered as adjunctive therapy for adults with refractory epilepsy.
Belgian biopharmaceutical firm UCB revealed results of a Phase III trial at the 61st annual meeting of the American Epilepsy Society in Philadelphia.
“These data show that the once-daily, extended-release formulation of Keppra reduced the frequency of partial onset seizures in patients with uncontrolled epilepsy and was generally well tolerated,” said Iris Loew-Friedrich, MD, PhD, Global Head of Development, UCB.
The Phase III, multicentre, randomised, double-blind, placebo-controlled study evaluated efficacy, safety, and tolerability of extended-release levetiracetam tablets (2x500mg) once-daily as adjunctive therapy in 158 refractory epilepsy patients, 12 to 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.
“In this study with a new formulation of Keppra about one in ten patients with refractory partial onset epilepsy achieved seizure freedom,” said Dr Jukka Peltola, Department of Neurology Tampere University Hospital, Finland.
“There is an ongoing need for new antiepileptic drug options and extended release formulations offer the potential advantages of convenience and improved patient compliance.”
UCB is in the process of submitting a New Drug Application (NDA) for the use of Keppra XR in the adjunctive treatment of partial onset seizures in adults with epilepsy to the US Food and Drug Administration (FDA).