On November 8, 2013, FDA approved Aptiom® (eslicarbazepine acetate), manufactured by Sunovion Pharmaceuticals ("Sunovion"), as a once-daily, immediate-release, adjunctive therapy for partial-onset seizures associated with epilepsy in adults 18 years or older. Partial or localized seizures affect only part of the brain at onset and are the most common type of seizure in epilepsy patients. Seizures can cause a wide range of symptoms, including repetitive limb movements, unusual behavior, and generalized convulsions with loss of consciousness and can have serious consequences, including injury and death. Epilepsy is one of the most common neurological disorders affecting nearly 2.2 million people in the U.S.
Aptiom® is an oral drug that stabilizes the inactive state of voltage-gated sodium channels and blocks T-type voltage-gated calcium channels. Sunovion recommends treatment using 400 mg once daily initially for one week followed by a dosage increase to a recommended maintenance dosage of 800 mg once daily. The maximum recommended maintenance dosage is 1,200 mg once daily. FDA noted that existing treatments do not achieve satisfactory seizure control from existing treatments. Sunovion, the U.S.-based unit of the Japanese drug maker Dainippon Sumitomo Pharma Co., expects Aptiom® to be available in U.S. pharmacies in the second quarter of 2014. FDA did not classify Aptiom® as a controlled substance.
Sunivion submitted Aptiom® for approval based on three, large phase 3 randomized, double-blind, placebo-controlled, safety and efficacy trials that included more than 1,400 patients with partial-onset seizures inadequately controlled by one to three concomitant, antiepileptic drugs, including carbamazepine, lamotrigine, valproic acid, and levetiracetam. These trials, jointly performed with BIAL-Portela & Ca, S.A. ("BIAL"), demonstrated a statistically-significant reduction in standardized seizure frequency compared to placebo. Significantly more treated patients had a seizure frequency reduction of 50% or more from baseline (41% compared to 22%).