Health Canada approves APTIOM (eslicarbazepine acetate) for epilepsy
Sunovion Pharmaceuticals Canada has announced that Health Canada approved APTIOM (eslicarbazepine acetate) for use as a once-daily adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy who are not satisfactorily controlled with conventional therapy. APTIOM is not indicated for use in patients under 18 years of age.
Epilepsy is one of the most common neurological disorders and according to Epilepsy Canada, it affects 0.6% of the population and each year approximately 15,500 people learn they have epilepsy. Partial-onset seizures are the most prevalent seizure type, accounting for 60% of new epilepsy diagnoses and approximately one third of patients do not have adequate seizure control.
The approval of APTIOM is based on three phase III randomized, double-blind, placebo-controlled, safety and efficacy trials (Studies BIA-2093-301, BIA-2093-302 and BIA-2093-304), which included more than 1,400 people living with partial-onset seizures inadequately controlled by one to three concomitant AEDs (including carbamazepine, lamotrigine, valproic acid and levetiracetam). In these global studies, treatment with APTIOM demonstrated statistically significant reductions in standardized seizure frequency versus placebo, and significantly more APTIOM treated patients experienced seizure frequency reduction of 50% or more from baseline (41% compared to 22% for placebo-treated patients).
The most frequently reported adverse reactions in patients taking APTIOM were dizziness, somnolence, headache, nausea, diplopia, vomiting, fatigue, ataxia, vision blurred and vertigo.