FDA Accepts NDA Resubmission for Stedesa for Partial-Onset Seizures
Sunovion announced that the FDA has accepted for review its New Drug Application (NDA) resubmission for Stedesa (eslicarbazepine acetate) for use as a once-daily adjunctive therapy in the treatment of partial-onset seizures in patient 18 years and older with epilepsy. Stedesa is an investigational voltage-gated sodium and T-type calcium channel blocker.
The submission is supported by data from three Phase 3 randomized, double-blind, placebo-controlled 12-week maintenance trials of similar study design, which included more than 1,300 patients with partial-onset seizures in 35 countries, including the United States. Treatment with Stedesa demonstrated statistically significant reductions in standardized seizure frequency when used as adjunctive therapy.
Sunovion is also conducting clinical trials to evaluate eslicarbazepine acetate as monotherapy in the treatment of partial-onset seizures in adult patients with epilepsy.For more information call (800) 739-0565 or visit www.sunovion.com