Aptiom

APTIOM is a member of the dibenzazepine carboxamide family of antiepileptic drugs (AEDs), an established class of medicines. APTIOM is approved in Canada as monotherapy for the treatment of POS in adults, as adjunctive therapy for the treatment of partial-onset seizures (POS) in adults with epilepsy that are not satisfactorily controlled with conventional therapy and as adjunctive therapy for the treatment of POS in adolescents and children above six years of age. The precise mechanism(s) by which eslicarbazepine, the primary active metabolite of APTIOM, exerts anticonvulsant activity is unknown but is thought to involve inhibition of voltage-gated sodium channels. APTIOM can be taken whole or crushed, with or without food. The initial research and development of eslicarbazepine acetate was performed by BIAL, a privately held Portuguese research-based pharmaceutical company. Sunovion acquired the rights to eslicarbazepine acetate in the United States and Canada markets under an exclusive license from BIAL. APTIOM is approved in the U.S. for the treatment of partial-onset seizures in adults, adolescents and children (four years of age and older). APTIOM is not classified as a controlled substance by the U.S. Food and Drug Administration (FDA). BIAL gained approval for eslicarbazepine acetate from the European Medicines Agency (EMA) in April 2009, as adjunctive therapy in adult patients with partial-onset seizures with or without secondary generalization; in December 2016, as adjunctive treatment for patients above six years of age with partial-onset seizures with or without secondary generalization; and in March 2017, as monotherapy in the treatment of partial-onset seizures, with or without secondary generalization, in adults with newly diagnosed epilepsy. In Europe, the product is marketed under the trade name Zebinix ®.