Sunovion Pharmaceuticals Inc. announced that Health Canada has approved the use of Aptiom (eslicarbazepine acetate) as monotherapy for partial-onset seizures in adults with epilepsy. All patients who participated in the monotherapy trial were newly or recently diagnosed with epilepsy.
APTIOM is now indicated in Canada as monotherapy and as adjunctive therapy for the treatment of partial-onset seizures (POS) in adults with epilepsy.
Partial-onset seizures are the most common type of seizures experienced by people living with epilepsy and, given these seizure’s unpredictable nature, can have a significant impact on their lives, said Eduard Bercovici, M.D., Epileptologist, director of the Southern Ontario Epilepsy Clinic. This new indication for APTIOM in Canada helps provide an additional treatment option for health care professionals and patients with partial-onset seizures.
The SNDS approval is supported by data from a Phase 3, double-blind, active controlled, non-inferiority study in which APTIOM met its primary efficacy endpoint of non-inferiority to the active comparator, carbamazepine controlled release (CBZ-CR).