STEDESA™ brand eslicarbazepine acetate is an antiepileptic product candidate that Sepracor licensed from BIAL-Portela & Ca, S.A. in December 2007. We submitted a New Drug Application (NDA) for this compound to the U.S. Food and Drug Administration (FDA) for adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy in March 2009. The NDA has been accepted for filing and is under formal FDA review.
In August 2009, Sepracor's wholly owned subsidiary, Sepracor Pharmaceuticals, Inc. submitted an application to the Therapeutic Products Directorate (TPD) of Health Canada for STEDESA.
STEDESA, a new chemical entity, is a novel voltage-gated sodium channel blocker. STEDESA has been studied in three Phase III, 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 eslicarbazepine acetate or placebo, and after a two-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 U.S. Food and Drug Administration (FDA) approval of STEDESA for adjunctive therapy with once-daily doses of 800 mg and 1200 mg in the treatment of partial-onset seizures in adults with epilepsy.
Epilepsy
Epilepsy is one of the most common neurological diseases that, according to the Epilepsy Foundation, afflicts more than 3 million people in the United States.1 Treatment of partial-onset seizures, the most common type of epilepsy, presents a constant challenge - up to 58% of patients with partial-onset seizures do not achieve seizure control with current antiepileptic drugs.2
Epilepsy is characterized by abnormal firing of impulses from nerve cells in the brain. In partial-onset epilepsy, these bursts of electrical activity are initially focused in specific areas of the brain, but may become more generalized, with symptoms varying according to the affected areas. Nerve impulses are triggered via voltage-gated sodium channels in the nerve cell membrane.
1 The Epilepsy Foundation of America® web site http://www.epilepsyfoundation.org/about/statistics.cfm, accessed May 27, 2009.
2 Brodie MJ. Management strategies for refractory localization-related seizures. Epilepsia 2001;42(Suppl 3):27-30.