Sepracor announced that the FDA has accepted for review its New Drug Application (NDA) for Stedesa (eslicarbazepine acetate), a treatment for partial-onset seizures in adults with epilepsy. This NDA submission includes data from three Phase 3, multi-center, randomized, placebo-controlled trials, which involved more than 1,000 patients from 23 countries. Patients involved in the trials had a history of at least four partial-onset seizures per month despite treatment with one to three concomitant antiepileptic drugs. During the trials, patients were randomized to Stedesa or placebo, and after a 2-week titration period, were assessed over a 12-week maintenance period with continued follow-up over a one-year, open-label period.
Stedesa is a voltage-gated sodium channel blocker.
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