Sunovion Pharmaceuticals Canada Inc. Announces Health Canada Approval of APTIOM(TM) (eslicarbazepine acetate) as a Once-Daily A

 Sunovion Pharmaceuticals Canada Inc. Announces Health Canada Approval of  APTIOM(TM) (eslicarbazepine acetate) as a Once-Daily Adjunctive Treatment for  Partial-Onset Seizures in Patients with Epilepsy  MISSISSAUGA, ON, July 11, 2014 /CNW/ - Sunovion Pharmaceuticals Canada Inc.  (Sunovion) today announced that Health Canada approved APTIOM(TM)  (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(TM) 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 0.6% 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 60% of new epilepsy diagnoses(1) and  approximately one third of patients do not have adequate seizure control(5).  The approval of APTIOM(TM) is based on three Phase 3 randomized, 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(TM)  demonstrated statistically significant reductions in standardized seizure  frequency versus placebo, and significantly more APTIOM(TM) treated patients  experienced seizure frequency reduction of 50% or more from baseline (41%  compared to 22% for placebo-treated patients).  The most frequently reported adverse reactions in patients taking APTIOM(TM)  were dizziness, somnolence, headache, nausea, diplopia, vomiting, fatigue,  ataxia, vision blurred, and vertigo.  "The approval of APTIOM(TM )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."  About Partial-Onset Seizures Epilepsy is a chronic neurological condition  characterized by recurrent seizures resulting from abnormal firing of impulses  from nerve cells in the brain(2). In partial-onset seizures, these bursts of  electrical activity are initially focused in specific areas of the brain, but  may become more widespread, with symptoms varying according to the affected  areas(3,4).  About APTIOM(TM )APTIOM(TM), a voltage-gated sodium channel inhibitor, is a  prescription medicine approved for use as adjunctive treatment of  partial-onset seizures. Treatment with APTIOM(TM) 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 license to further develop and  commercialize eslicarbazepine acetate in the U.S. and Canadian markets from  BIAL. Eslicarbazepine acetate was approved on November 8, 2013, by the U.S.  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 license 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 generalization and is  currently marketed in Europe under the agreement.  About Sunovion Pharmaceuticals Canada Inc.  Sunovion Pharmaceuticals Canada  Inc. is focused on the development and commercialization of prescription  products in Canada. In addition to commercializing Sunovion Pharmaceuticals  Inc.'s products, our strategy is to license pharmaceutical products that meet  the needs of patients and the Canadian health care system, currently focusing  on cardiovascular disease, infectious disease and central nervous system (CNS)  disorders.  More information about Sunovion Pharmaceuticals Canada Inc. is  available at  Sunovion Pharmaceuticals Canada Inc., a subsidiary of the U.S. based Sunovion  Pharmaceuticals Inc., is headquartered in Mississauga, Ontario.  Sunovion  Pharmaceuticals Inc., an indirect, wholly-owned subsidiary of Sumitomo  Dainippon Pharma Co., Ltd., is headquartered in Marlborough, Mass.  More  information about Sunovion Pharmaceuticals Inc. is available at  About Sumitomo Dainippon Pharma Co., Ltd.   Sumitomo Dainippon Pharma is a  top-ten listed pharmaceutical company in Japan with a diverse portfolio of  pharmaceutical, animal health and food and specialty products. Sumitomo  Dainippon Pharma aims to produce innovative pharmaceutical products in the  Psychiatry & Neurology area and the Oncology area, 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 about 7,000  employees worldwide. Additional information about Sumitomo Dainippon Pharma is  available through its corporate website at  APTIOM is under license from BIAL.  1. 2. 3. cfm 4. 5.     Kwan  P, Brodie MJ. N Eng J Med. 2000; 342:314-319  For a copy of this release or any recent release, visit Sunovion's web site at    SOURCE  Sunovion Pharmaceuticals Canada Inc.  Douglas Reynolds, President, Sunovion Pharmaceuticals Canada Inc.,  905-814-9145,; Patricia Moriarty, Senior  Director, Corporate Communications, Sunovion Pharmaceuticals Inc.,  508-787-4279,  To view this news release in HTML formatting, please use the following URL:  CO: Sunovion Pharmaceuticals Canada Inc. ST: Ontario NI: HEA BTC MTC NP  
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