SEP-0002093* is an anti-epileptic candidate, eslicarbazepine acetate, which we licensed from Bial-Portela & Ca, S.A. in December 2007. We are currently preparing a New Drug Application (NDA) for this compound that we expect to submit to the U.S. Food and Drug Administration (FDA) at the end of 2008 or early 2009. This NDA will include results from three Phase III studies that were conducted in 22 countries, and included more than 1,000 patients.
SEP-0002093 is designed for once-daily administration and to offer additional seizure control, simpler dosage titration and improved quality of life to patients with partial epilepsy.
*referred to by Bial as BIA 2-093
Epilepsy
According to the National Institute of Neurological Disorders and Stroke, epilepsy is a brain disorder in which neurons in the brain signal abnormally causing strange sensations, emotions and behavior, or sometimes convulsions, muscle spasms and loss of consciousness. More than two million people in the U.S. have been diagnosed with epilepsy or have experienced a seizure.