Health Canada approves Sunovion’s Aptiom to treat partial-onset seizures in epilepsy patients

Health Canada has supported Sunovion Pharmaceuticals Canada's Aptiom, a Voltage Dependent T Type Calcium Channel Subunit Alpha 1G Drugs Development Market 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 endorsement 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.

The three randomized, twofold blind, fake treatment controlled Phase III clinical trials included in excess of 1,400 patients with partial-onset seizures inadequately controlled by one to three concomitant antiepileptic drugs, including carbamazepine, lamotrigine, valproic acid and levetiracetam.

"Adequate seizure control remains an unmet medical requirement for a significant number of patients and Sunovion is committed to providing a treatment option to address this need."

These studies showed that treatment with Aptiom demonstrated statistically significant reductions in standardized seizure recurrence versus fake treatment, and significantly more Aptiom treated patients experienced seizure recurrence reduction of half or more from baseline.

Dizziness, lethargy, cerebral pain, queasiness, diplopia, vomiting, fatigue, ataxia, vision obscured, and vertigo are the most frequently reported unfriendly reactions in patients taking Aptiom.

Sunovion Pharmaceuticals Canada president Douglas Reynolds said: "Adequate seizure control remains an unmet medical requirement for a significant number of patients and Sunovion is committed to providing a treatment option to address this need."

Portuguese-based BIAL had carried out initial groundwork and development of eslicarbazepine acetate and Sunovion acquired the rights under an exclusive license to further create and commercialize eslicarbazepine acetate in the US and Canadian markets from BIAL.

The US Food and Drug Administration had endorsed eslicarbazepine acetate in November 2013 as adjunctive treatment of partial-onset seizures.

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