Sunovion Pharmaceuticals Canada Inc. Announces Health Canada Acceptance for Review of the New Drug Submission of eslicarbazepine

Sunovion Pharmaceuticals Canada Inc. Announces Health Canada Acceptance for 
Review of the New Drug Submission of eslicarbazepine acetate as a Once-Daily 
Adjunctive Therapy for Partial-onset Seizures in Adults with Epilepsy 
MISSISSAUGA, ON, Sept. 18, 2013 /CNW/ - Sunovion Pharmaceuticals Canada Inc. 
(Sunovion) today announced that Health Canada has accepted for review the 
company's New Drug Submission (NDS) for eslicarbazepine acetate for use as a 
once-daily adjunctive therapy in the treatment of partial-onset seizures in 
patients 18 years of age and older with epilepsy. The efficacy and safety of 
eslicarbazepine acetate as an adjunctive or monotherapy treatment for 
partial-onset seizures in adults living with epilepsy has not yet been 
"The acceptance of our eslicarbazepine acetate submission 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. If approved, 
eslicarbazepine acetate may offer adult patients an effective,adjunctive 
treatment option for better managing partial-onset seizures". 
The NDS for eslicarbazepine acetate is supported by data from three Phase III 
randomized, double-blind, placebo-controlled 12-week maintenance trials of 
similar study design, which included more than 1,400 patients with 
partial-onset seizures. In these trials, treatment with eslicarbazepine 
acetate demonstrated statistically significant reductions in standardized 
seizure frequency when used as adjunctive therapy. The most commonly reported 
adverse events in the clinical trials were dizziness, somnolence, headache, 
nausea, diplopia, vomiting, fatigue, ataxia, blurred vision and vertigo. 
About Partial-Onset Seizures
Epilepsy is one of the most common neurological disorders(1) and is 
characterized by recurrent seizures, with abnormal firing of impulses from 
nerve cells in the brain(2). In partial-onset seizures, the abnormal 
electrical activity begins in specific areas of the brain, but may become more 
widespread, with symptoms varying according to the affected areas(3,4). 
About Eslicarbazepine Acetate
Eslicarbazepine acetate is an investigational voltage-gated sodium and T-type 
calcium channel blocker that has been evaluated in three Phase III clinical 
trials involving more than 1,400 patients with partial-onset seizures 
worldwide. The initial research and development of eslicarbazepine acetate was 
performed by BIAL-Portela & C(a), S.A., a privately held Portuguese research 
based pharmaceutical company. Subsequently, Sunovion Pharmaceuticals Inc., 
acquired the rights to further develop and commercialize eslicarbazepine 
acetate in the U.S. and Canadian markets from BIAL. 
About Sunovion Pharmaceuticals Canada Inc. 
Sunovion Pharmaceuticals Canada Inc., headquartered in Mississauga, Ontario, 
is a subsidiary of Sunovion Pharmaceuticals Inc. Sunovion Pharmaceuticals 
Inc., an indirect, wholly-owned subsidiary of Dainippon Sumitomo Pharma Co., 
Ltd., is headquartered in Marlborough, Mass. More information about Sunovion 
Pharmaceuticals Inc. is available at 
Sunovion Pharmaceuticals Canada Inc., is focused on the development and 
commercialization of prescription products in Canada. In addition to 
commercializing 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 
About Dainippon Sumitomo Pharma Co., Ltd. (DSP) 
DSP is a top-ten listed pharmaceutical company in Japan with a diverse 
portfolio of pharmaceutical, animal health and food and specialty products. 
DSP aims to produce innovative pharmaceutical products in the Psychiatry & 
Neurology field, which has been designated as one of the two key therapeutic 
areas. DSP is based on the merger in 2005 between Dainippon Pharmaceutical 
Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, DSP has more than 
7,000 employees worldwide. Additional information about DSP is available 
through its corporate website at 
1. Statistics Canada - CANSIM Table 105-1300
  4. dons/part_3/chapter_22.html 
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 
Coomunications Sunovion Pharmaceuticals Inc. 508-787-4279 
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CO: Sunovion Pharmaceuticals Canada Inc.
ST: Ontario
-0- Sep/18/2013 13:00 GMT
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