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
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 www.sunovion.ca.
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 www.ds-pharma.com.
APTIOM is under license from BIAL.
1. http://www.epilepsy.ca/en-CA/Facts/Epilepsy-Facts.html 2.
cfm 4. http://www.dartmouth.edu/~dons/part_3/chapter_22.html 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, email@example.com; Patricia Moriarty, Senior
Director, Corporate Communications, Sunovion Pharmaceuticals Inc.,
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