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 established.
"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
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 disorders1 and is characterized by recurrent seizures, with abnormal firing of
impulses from nerve cells in the brain2. 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 areas3,4.
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 & Ca, 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.
Statistics Canada - CANSIM Table 105-1300
For a copy of this release or any recent release,
visit Sunovion's web site at www.sunovion.ca
SOURCE Sunovion Pharmaceuticals Canada Inc.