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Sunovion gets Canadian approval for Aptiom to treat partial-onset seizures

Sunovion Pharmaceuticals Canada has received approval from Health Canada for Aptiom (eslicarbazepine acetate) for use as a once-daily adjunctive drug (AED) to treat partial-onset seizures in patients with epilepsy who are not satisfactorily controlled with conventional therapy.

Sunovion-Aptiom

The company said that Aptiom is not indicated for use in patients under 18 years of age.

The approval is based on three Phase III randomized, double-blind, placebo-controlled, safety and efficacy trials BIA-2093-301, BIA-2093-302 and BIA-2093-304.

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, were involved in these Phase III trials.

In these trials, treatment with Aptiom showed 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.

Dizziness, somnolence, headache, nausea, diplopia, vomiting, fatigue, ataxia, vision blurred, and vertigo are the most frequently reported adverse reactions in patients taking Aptiom.

Sunovion Pharmaceuticals Canada president Douglas Reynolds said the approval of Aptiom is an important milestone not only for the company, but for thousands of Canadians living with, and affected by epilepsy.

"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," Reynolds said.

Aptiom is a voltage-gated sodium channel inhibitor approved a prescription medicine for use as adjunctive treatment of partial-onset seizures.

Sunovion Pharmaceuticals Canada is a subsidiary of the US-based Sunovion Pharmaceuticals, which is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma.


Image: Sunovion’s APTIOM is not indicated for use in patients under 18 years of age. Photo: courtesy of Business Wire