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R&D In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

UCB antiepileptic Rikelta starts Phase III trials: Belgian biopharmaceutical company UCB announces the initiation of three multinational Phase III trials for antiepileptic Rikelta (brivaracetam) as adjunctive therapy in patients with refractory partial-onset epilepsy. Strong results from two Phase IIb trials, including in patients on fellow UCB antiepileptic cash cow Keppra (levetiracetam), supported the move into Phase III, UCB said. Approval of brivaracetam would fill the hole made by Mylan's plan to launch generic Keppra on Nov. 1, 2008. First results from the Rikelta trials, which are slated to enroll 1,300 patients between 16 and 70 years old, are expected in the third quarter of 2009. Two of the studies will enroll patients whose epilepsy is not fully controlled by one or two other AEDs, while the third, a flexible-dose trial, will assess patients with uncontrolled partial onset or primary generalized seizures...
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