Sepracor announced that it has submitted a New Drug Application (NDA) to the FDA for the use of Stedesa (eslicarbazepine acetate) as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. Stedesa is Sepracor’s novel voltage-gated sodium channel blocker that has been designed to reduce the frequency of partial-onset seizures. The NDA submission includes data from three Phase 3, multi-center, randomized, placebo-controlled trials, which involved more than 1,000 patients from 23 countries. 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.
Sepracor is seeking approval of Stedesa for adjunctive therapy with once-daily maintenance doses of 800mg and 1200mg in the treatment of partial-onset seizures in adults with epilepsy.
For more information call (800) 739-0565 or visit www.sepracor.com.