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 www.sunovion.com
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 www.sunovion.ca.
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 www.ds-pharma.com.
1. Statistics Canada - CANSIM Table 105-1300
4. http://www.dartmouth.edu/ dons/part_3/chapter_22.html
For a copy of this release or any recent release,
visit Sunovion's web site at www.sunovion.ca
SOURCE Sunovion Pharmaceuticals Canada Inc.
Douglas Reynolds President Sunovion Pharmaceuticals Canada Inc. 905-814-9145
email@example.com Patricia Moriarty Senior Director, Corporate
Coomunications Sunovion Pharmaceuticals Inc. 508-787-4279
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