Health Canada has approved Sunovion Pharmaceuticals Canada’s Aptiom, a voltage-gated sodium channel inhibitor, for use as a once-daily adjunctive therapy for treatment of partial-onset seizures in patients with epilepsy who are not satisfactorily controlled with conventional therapy.
Aptiom’s approval in Canada is supported by data from three Phase III safety and efficacy trials, including BIA-2093-301, BIA-2093-302 and BIA-2093-304.
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The three randomised, double-blind, placebo-controlled Phase III clinical trials 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 studies showed that treatment with Aptiom demonstrated statistically significant reductions in standardised seizure frequency versus placebo, and significantly more Aptiom treated patients experienced seizure frequency reduction of 50% or more from baseline.
Dizziness, somnolence, headache, nausea, diplopia, vomiting, fatigue, ataxia, vision blurred, and vertigo are the most frequently reported adverse reactions in patients taking Aptiom.
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Sunovion Pharmaceuticals Canada president Douglas Reynolds said: "Adequate seizure control remains an unmet medical need for a significant number of patients and Sunovion is committed to providing a treatment option to address this need."
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By GlobalDataPortuguese-based BIAL had performed initial research and development of eslicarbazepine acetate and Sunovion acquired the rights under an exclusive license to further develop and commercialise eslicarbazepine acetate in the US and Canadian markets from BIAL.
The US Food and Drug Administration had approved eslicarbazepine acetate in November 2013 as adjunctive treatment of partial-onset seizures.
Image: Aptiom is a once-daily antiepileptic drug indicated for use as adjunctive treatment of partial-onset seizures. Photo: courtesy of Business Wire/ Sunovion Pharmaceuticals Canada Inc.
