Sepracor files NDA for seizure drug

Sepracor, a research-based pharmaceutical company, has submitted a new drug application to the FDA for the use of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. The proposed trade name for eslicarbazepine acetate is Stedesa.

Stedesa, a new chemical entity, is a novel voltage-gated sodium channel blocker that has been designed to reduce the frequency of partial-onset seizures.

Under the Prescription Drug User Fee Act, the FDA has 60 days after submission to review a new drug application (NDA) in order to determine if the application may be accepted for filing. The acceptance of the filing of an application means that the FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review.

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.

Mark Corrigan, executive vice president of R&D at Sepracor, said: If approved, Stedesa has the potential to be a meaningful new treatment for patients with epilepsy. Clinical studies have indicated that Stedesa has the potential to reduce seizure frequency, provide simpler dosage titration and reduce side effects with once-daily dosing.