21 September 2018 - - Health Canada approved a Supplemental New Drug Submission to expand the indication for US-based Sunovion Pharmaceuticals Inc's antiepileptic drug Aptiom (eslicarbazepine acetate) to include use as an adjunctive therapy for the treatment of partial-onset seizures in adolescents and children above six years of age who are not satisfactorily controlled with conventional therapy, the company said.

Aptiom is also approved in Canada as monotherapy and adjunctive therapy for the treatment of POS in adults living with epilepsy. Aptiom is a once-daily, immediate release AED that can be taken whole or crushed, with or without food.

The safety and efficacy of Aptiom as an adjunctive therapy in the treatment of POS in adolescents and children above six years of age have been established using data from clinical studies in pediatric patients and a population pharmacokinetic study, which was used to support the recommended dosing regimen in the pediatric population.

The safety and efficacy in pediatric patients six years of age and below have not been established.

Aptiom is a member of the dibenzazepine carboxamide family of antiepileptic drugs, an established class of medicines. Aptiom is approved in Canada as monotherapy for the treatment of POS in adults, as adjunctive therapy for the treatment of partial-onset seizures in adults with epilepsy that are not satisfactorily controlled with conventional therapy and as adjunctive therapy for the treatment of POS in adolescents and children above six years of age.

The precise mechanism(s) by which eslicarbazepine, the primary active metabolite of Aptiom, exerts anticonvulsant activity is unknown but is thought to involve inhibition of voltage-gated sodium channels. Aptiom can be taken whole or crushed, with or without food.

The initial research and development of eslicarbazepine acetate was performed by BIAL, a privately held Portuguese research-based pharmaceutical company. Sunovion acquired the rights to eslicarbazepine acetate in the United States and Canada markets under an exclusive license from BIAL.

Aptiom is approved in the US for the treatment of partial-onset seizures in adults, adolescents and children (four years of age and older). Aptiom is not classified as a controlled substance by the US Food and Drug Administration.

BIAL gained approval for eslicarbazepine acetate from the European Medicines Agency in April 2009, as adjunctive therapy in adult patients with partial-onset seizures with or without secondary generalization; in December 2016, as adjunctive treatment for patients above six years of age with partial-onset seizures with or without secondary generalization; and in March 2017, as monotherapy in the treatment of partial-onset seizures, with or without secondary generalization, in adults with newly diagnosed epilepsy.

In Europe, the product is marketed under the trade name Zebinix.

Epilepsy is a neurological condition that manifests as unprovoked seizures, which are caused by abnormal firing of impulses from nerve cells in the brain.

Epilepsy is one of the most common neurological diseases globally, affecting approximately 50m people worldwide.

An estimated 300,000 Canadians live with epilepsy.

Each year in Canada, an average of 15,500 people learn they have epilepsy; 75-85% are diagnosed before age 18.

Partial-onset seizures are characterised by bursts of electrical activity that are initially focused in specific areas of the brain and may become more widespread, with symptoms varying according to the affected areas.

The unpredictable nature of seizures may have a significant impact on those with epilepsy. Reducing the frequency of seizures may lessen the burden of epilepsy.

With approximately one-third of people living with epilepsy still unable to control seizures, there continues to be a need for new therapies.

Up to 40% of people living with epilepsy do not respond to the first or second monotherapy, and approximately 36% fail to achieve adequate control of seizures despite the use of two or more antiepileptic medications.

Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions.

Sunovion's vision is to lead the way to a healthier world. The company's spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives.

With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions.

Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc.

Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the US, China and the European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry and Neurology area, the Oncology area and Regenerative medicine/Cell therapy field, which have been designated as the focus therapeutic areas.

Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide.

Aptiom (eslicarbazepine acetate) is a prescription medicine to treat partial-onset seizures in patients 4 years of age and older.