Sunovion Pharmaceuticals Inc. Announces FDA Approval of Aptiom® (eslicarbazepine acetate) as Once-Daily Adjunctive Treatment of Partial-Onset Seizures Business Wire 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 diagnoses.^2 “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 with epilepsy.” 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 placebo-treated patients). 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 About APTIOM 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 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. 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. Indication 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 reactions. 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 weakness. 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 balance. 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 or vomiting. 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) inhalation aerosol. 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 www.ds-pharma.com. 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. <“http://www.epilepsyfoundation.org/aboutepilepsy/seizures/partialseizures/index.cfm> ^5 Dartmouth Medical School. “Disorders of the Central Nervous System: A Primer (Chapter 22: Epilepsy).” Accessed 5 September 2013. <http://www.dartmouth.edu/~dons/part_3/chapter_22.html> ^6 Brodie MJ, Barry SJE, Bamagous GA, Norrie JD, Kwan P. Patterns of treatment response in newly diagnosed epilepsy. Neurology. 2012;78:1548-1554. Contact: Sunovion Pharmaceuticals Inc. Patricia Moriarty, 508-787-4279 Senior Director, Corporate Communications email@example.com
Sunovion Pharmaceuticals Inc. Announces FDA Approval of Aptiom® (eslicarbazepine acetate) as Once-Daily Adjunctive Treatment of
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