Sunovion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration has accepted for review the Company’s New Drug Application resubmission for STEDESA (eslicarbazepine acetate) for use as a once-daily adjunctive therapy in the treatment of partial-onset seizures in patients 18 years and older with epilepsy. STEDESA is the proposed trade name for eslicarbazepine acetate.
Partial seizures are the most common type of seizure seen in people with epilepsy. Epilepsy is a brain disorder in which there is abnormal or excessive activity of nerve cells in the brain. Partial seizures affect only a limited or localized area of the brain, but can spread to other parts of the brain. Seizures cause a wide range of symptoms, including repetitive limb movements (spasms), unusual behavior, and generalized convulsions with loss of consciousness.