MISSISSAUGA, ON, July 11, 2014 /CNW/ - Sunovion Pharmaceuticals Canada Inc. (Sunovion) today announced that Health Canada approved APTIOMTM (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. APTIOMTM 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 diagnoses1 and approximately one third of patients do not have adequate seizure control5.
The approval of APTIOMTM is based on three Phase 3 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 APTIOMTM demonstrated statistically significant reductions in standardized seizure frequency versus placebo, and significantly more APTIOMTM 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 APTIOMTM were dizziness, somnolence, headache, nausea, diplopia, vomiting, fatigue, ataxia, vision blurred, and vertigo.
"The approval of APTIOMTM is an important milestone not only for our company, but for thousands of Canadians living with, and affected by epile
|SOURCE Sunovion Pharmaceuticals Canada Inc.|
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