The Health Canada has approved Sunovion Pharmaceuticals Canada Inc's 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 0.6per cent 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 60per cent of new epilepsy diagnoses1 and approximately one third of patients do not have adequate seizure control5.
The approval of Aptiom is based on three Phase 3 randomised, 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 50per cent or more from baseline (41per cent compared to 22per cent 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 Aptiom is an important milestone not only for our company, but for thousands of Canadians living with, and affected by epilepsy." said Douglas Reynolds, President, Sunovion Pharmaceuticals Canada Inc.."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."
Epilepsy is a chronic neurological condition characterised by recurrent seizures resulting from abnormal firing of impulses from nerve cells in the brain2. In partial-onset seizures, these bursts of electrical activity are initially focussed in specific areas of the brain, but may become more widespread, with symptoms varying according to the affected areas.
Aptiom, a voltage-gated sodium channel inhibitor, is a prescription medicine approved for use as adjunctive treatment of partial-onset seizures. Treatment with Aptiom should be initiated at 400 mg once daily. After one week, dosage may be increased to the recommended maintenance dosage of 800 mg once daily. Some patients may benefit from the maximum recommended maintenance dosage of 1,200 mg once daily, although this dosage is associated with an increase in adverse reactions. The maximum dose of 1,200 mg daily should only be initiated after the patient has tolerated 800 mg daily for at least a week. For some patients, treatment may be initiated at 800 mg once daily if the need for additional seizure reduction outweighs an increased risk of adverse reactions during initiation. The initial research and development of eslicarbazepine acetate was performed by BIAL, a privately held Portuguese research-based pharmaceutical company. Subsequently, Sunovion acquired the rights under an exclusive licence to further develop and commercialise eslicarbazepine acetate in the US and Canadian markets from BIAL. Eslicarbazepine acetate was approved on November 8, 2013, by the US FDA as adjunctive treatment of partial-onset seizures.
In February 2009, Eisai Europe Limited, a European subsidiary of Eisai Co., Ltd. (Eisai), entered into a licence and co-promotion agreement with BIAL, which gave the rights to Eisai to sell eslicarbazepine acetate under the trade name Zebinix in Europe. Zebinix was approved by the European Commission on April 21, 2009 as adjunctive therapy in adult patients with partial-onset seizures with or without secondary generalisation and is currently marketed in Europe under the agreement.
Sunovion Pharmaceuticals Canada Inc. is focussed on the development and commercialisation of prescription products in Canada.