Sunovion Pharmaceuticals Inc. Announces FDA Approval of Aptiom®
(eslicarbazepine acetate) as Once-Daily Adjunctive Treatment of
MARLBOROUGH, Mass. -- November 8, 2013
Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food
and Drug Administration (FDA) approved Aptiom^® (eslicarbazepine acetate), an
antiepileptic drug (AED), for use as adjunctive treatment of partial-onset
seizures. Epilepsy is one of the most common neurological disorders and,
according to the Centers for Disease Control and Prevention, affects nearly
2.2 million people in the United States (U.S.).^1 Partial-onset seizures are
the most prevalent seizure type, accounting for 60% of new epilepsy
“Patients with partial-onset epilepsy often require adjunctive treatment to
achieve better seizure control,” said Dr. Joseph Sirven, M.D., Chair of
Neurology at Mayo Clinic in Arizona and Chair of the Epilepsy Foundation's
Professional Advisory Board. “APTIOM is an important new treatment option with
a well-established safety profile for healthcare providers and people living
The FDA has determined that APTIOM will not be classified as a controlled
substance. Sunovion expects APTIOM to be available in U.S. pharmacies in the
second quarter (April – June) of 2014.
The approval of APTIOM is based on three large 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, which were jointly performed with
BIAL-Portela & C^a, S.A. (BIAL), treatment with APTIOM demonstrated
statistically significant reductions in standardized seizure frequency versus
placebo, and significantly more APTIOM treated patients experienced seizure
frequency reduction of 50% or more from baseline (41% compared to 22% for
The most common side effects in patients taking APTIOM include dizziness,
somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia,
blurred vision and tremor. The rate of discontinuation as a result of any
adverse event was 14% for the 800 mg dose, 25% for the 1,200 mg dose and 7% in
subjects randomized to placebo.
"APTIOM will offer people with partial-onset seizures sustained seizure
reduction in a once-daily, immediate-release formulation," said Antony Loebel,
M.D., Executive Vice President and Chief Medical Officer at Sunovion. "The
approval today significantly expands the treatment options Sunovion offers to
patients with complex neurological disorders, and it marks the second FDA
approval action this year for the Company’s central nervous system products."
About Partial-Onset Seizures
Epilepsy is characterized by abnormal firing of impulses from nerve cells in
the brain.^3 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.^4,5 The
unpredictable nature of seizures can have a significant impact on those with
epilepsy, affecting a number of areas of daily living, including education,
employment, driving and recreation. Reducing the frequency of seizures can
greatly lessen the burden of epilepsy.^1 With approximately 30% of people
living with epilepsy still unable to control seizures, there continues to be a
need for new therapies.^6
APTIOM, a voltage-gated sodium channel inhibitor, is a prescription medicine
approved for use as adjunctive treatment of partial-onset seizures. Treatment
with APTIOM 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
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. 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.
Please see Important Safety Information below.
Sunovion Support™, the Sunovion patient assistance program, may help eligible
patients receive APTIOM at no charge to the patient when it becomes available.
Following the launch of APTIOM, more information on this program, including
eligibility criteria, may be found at www.SunovionSupport.com.
APTIOM (eslicarbazepine acetate) is a prescription medicine used with other
medicines to treat partial-onset seizures.
Important Safety Information
Do not take APTIOM if you are allergic to eslicarbazepine acetate, any of the
other ingredients in APTIOM or oxcarbazepine.
APTIOM may cause suicidal thoughts or actions, depression or mood problems.
Call your doctor right away if you experience these or any other effects or
APTIOM may cause serious skin rash or other serious allergic reactions, which
may affect organs or other parts of your body like the liver or blood cells.
Some symptoms may include: swelling of the face, eyes, lips or tongue, trouble
swallowing or breathing, yellowing of the skin or eyes or severe fatigue or
APTIOM may cause the level of sodium in your blood to be low. Symptoms may
include nausea, tiredness, lack of energy, irritability, confusion, muscle
weakness or muscle spasms, or more frequent or more severe seizures.
APTIOM may cause problems that can affect your nervous system including
dizziness, sleepiness, vision problems and difficulties with coordination and
APTIOM may slow your thinking or motor skills. Do not drive or operate heavy
machinery until you know how APTIOM affects you.
Do not stop taking APTIOM without first talking to your healthcare provider.
Stopping APTIOM suddenly can cause serious problems.
APTIOM may cause problems that can affect your liver. Symptoms of liver
problems include yellowing of your skin or the whites of your eyes and nausea
The most common side effects in patients taking APTIOM include dizziness,
sleepiness, nausea, headache, double vision, vomiting, feeling tired, problems
with coordination, blurred vision and shakiness.
You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
About Sunovion Pharmaceuticals Inc. (Sunovion)
Sunovion is a leading pharmaceutical company dedicated to discovering,
developing and commercializing therapeutic products that advance the science
of medicine in the Psychiatry & Neurology and Respiratory disease areas and
improve the lives of patients and their families. Sunovion’s drug development
program, together with its corporate development and licensing efforts, has
yielded a portfolio of pharmaceutical products including Aptiom^®
(eslicarbazepine acetate), Latuda^® (lurasidone HCl) tablets, Lunesta^®
(eszopiclone) tablets, Xopenex^® (levalbuterol HCI) inhalation solution,
Xopenex HFA^® (levalbuterol tartrate) inhalation aerosol, Brovana^®
(arformoterol tartrate) inhalation solution, Omnaris^® (ciclesonide) nasal
spray, Zetonna^® (ciclesonide) nasal aerosol and Alvesco^® (ciclesonide)
Sunovion, an indirect, wholly-owned U.S. subsidiary of Dainippon Sumitomo
Pharma Co., Ltd., is headquartered in Marlborough, Mass. More information
about Sunovion Pharmaceuticals Inc. is available at www.sunovion.com.
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 areaand the Oncology area, which have been designated
as the focus 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
LATUDA ^ is a registered trademark of Dainippon Sumitomo Pharma Co., Ltd.
LUNESTA, XOPENEX, XOPENEX HFA, and BROVANA are registered trademarks of
Sunovion Pharmaceuticals Inc. OMNARIS and ALVESCO are registered trademarks of
Takeda GmbH, used under license.
For a copy of this release, visit Sunovion’s web site at www.sunovion.com
©2013 Sunovion Pharmaceuticals Inc. All rights reserved.
^1 IOM (Institute of Medicine). 2012. Epilepsy across the spectrum: Promoting
health and understanding. Washington, DC: The National Academies Press.
^2 Hauser WA, Annegers JF, Kurland LT. Prevalence of Epilepsy in Rochester,
Minnesota: 1940-1980. Epilepsia. 1991;32:429-445.
^3 National Institutes of Health. “NINDS Epilepsy Information Page” Accessed 5
September 2013. <http://www.ninds.nih.gov/disorders/epilepsy/epilepsy.htm>
^4 Epilepsy Foundation. “Partial Seizures.” Accessed 5 September 2013.
^5 Dartmouth Medical School. “Disorders of the Central Nervous System: A
Primer (Chapter 22: Epilepsy).” Accessed 5 September 2013.
^6 Brodie MJ, Barry SJE, Bamagous GA, Norrie JD, Kwan P. Patterns of treatment
response in newly diagnosed epilepsy. Neurology. 2012;78:1548-1554.
Sunovion Pharmaceuticals Inc.
Patricia Moriarty, 508-787-4279
Senior Director, Corporate Communications
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