UCB Announces Positive Phase III Trial Results for Keppra XR
UCB announced results of a Phase III trial demonstrating that its antiepileptic drug (AED) in development Keppra XR(TM) (levetiracetam) extended-release tablets significantly reduced partial onset seizure frequency when administered as adjunctive therapy for adults with refractory epilepsy. These data were presented at a scientific exhibit at the 61st annual meeting of the American Epilepsy Society, 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, multicenter, randomized, double-blind, placebo-controlled study evaluated efficacy, safety, and tolerability of extended-release levetiracetam tablets (2x500 mg) 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, 24.0% of patients randomized 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 is in the process of submitting a New Drug Application (NDA) for the use of Keppra XR(TM) in the adjunctive treatment of partial onset seizures in adults with epilepsy to the U.S. Food and Drug Administration (FDA).
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