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Sunovion to Present Data on Aptiom® (eslicarbazepine acetate) at the American Academy of Neurology 2017 Annual MeetingSunovion Pharmaceuticals Inc. (Sunovion) will present nine posters supporting the use of Aptiom® (eslicarbazepine acetate) to treat partial-onset seizures (POS) at the American Academy of Neurology 2017 Annual Meeting (AAN 2017) to be held April 22-28, 2017, in Boston, Massachusetts. The poster presentations include data that support the short-term and long-term safety and efficacy of APTIOM monotherapy in adults with POS, as well as analyses to support a supplemental new drug application (sNDA) for the use of APTIOM in pediatric patients four years of age and older. APTIOM is currently approved in the U.S. for use as monotherapy or adjunctive therapy for POS in adults. "We are dedicated to furthering the understanding of APTIOM for the treatment of both adult and pediatric patients with partial-onset seizures," said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. "We look forward to presenting this broad selection of data and analyses that underscore our continued commitment to advancing the understanding of epilepsy and the need for safe and effective treatment options for partial-onset seizures." Sunovion recently announced submission of a sNDA to the U.S. Food and Drug Administration (FDA) to expand the indication for APTIOM to include use as monotherapy or adjunctive therapy for the treatment of POS in children four years of age and older. Sunovion presentations include:
About APTIOM® (eslicarbazepine acetate) The initial research and development of eslicarbazepine acetate was performed by BIAL-Portela & C.a, S.A. (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 United States and Canada markets from BIAL. APTIOM is approved in Canada for use as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy who are not satisfactorily controlled with conventional therapy. BIAL gained approval for eslicarbazepine acetate from the European Medicines Agency in April 2009, as adjunctive therapy in adult patients with partial-onset seizures with or without secondary generalization and in December 2016, as adjunctive treatment for patients above age six years with partial-onset seizures with or without secondary generalization. In Europe, the product is marketed under the trade name Zebinix®.
About Epilepsy and Partial-Onset Seizures Please see Important Safety Information below.
INDICATION:
IMPORTANT SAFETY INFORMATION: Suicidal behavior and ideation: Antiepileptic drugs, including APTIOM, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your doctor right away if you have any of the following symptoms, especially if they are new, worse or worry you: thoughts about suicide or dying; attempting to commit suicide; new or worse depression, anxiety, or irritability; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood. Allergic reactions: APTIOM may cause serious skin rash or other serious allergic reactions that may affect organs or other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your doctor right away if you experience any of the following symptoms: swelling of the face, eyes, lips, or tongue; trouble swallowing or breathing; hives; fever, swollen glands, or sore throat that do not go away or come and go; painful sores in the mouth or around your eyes; yellowing of the skin or eyes; unusual bruising or bleeding; severe fatigue or weakness; severe muscle pain; or frequent infections or infections that do not go away. Low salt (sodium) levels in the blood: 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. Some medicines can also cause low sodium in your blood. Be sure to tell your health care provider about all the other medicines that you are taking. Nervous system problems: APTIOM may cause problems that can affect your nervous system, including dizziness, sleepiness, vision problems, trouble concentrating, 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. Liver 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, nausea or vomiting, loss of appetite, stomach pain, or dark urine. Most common adverse reactions: 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. Drug interactions: Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking APTIOM with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your health care provider. Especially tell your health care provider if you take oxcarbazepine, carbamazepine, phenobarbital, phenytoin, primidone, clobazam, omeprazole, simvastatin, rosuvastatin, or birth control medicine. Discontinuation: Do not stop taking APTIOM without first talking to your health care provider. Stopping APTIOM suddenly can cause serious problems. Pregnancy and lactation: APTIOM may cause your birth control medicine to be less effective. Talk to your health care provider about the best birth control method to use. APTIOM may harm your unborn baby. APTIOM passes into breast milk. Tell your health care provider if you are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. You and your health care provider will decide if you should take APTIOM. If you become pregnant while taking APTIOM, talk to your health care provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334. Get medical help right away if you have any of the symptoms listed above. 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. For more information, please see the APTIOM Medication Guide and Full Prescribing Information. APTIOM is used under license from BIAL.
About Sunovion Pharmaceuticals Inc. (Sunovion) Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, and Sunovion CNS Development Canada ULC, based in Toronto, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the company's web sites: www.sunovion.com, www.sunovion.eu and www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.
About Sumitomo Dainippon Pharma Co., Ltd.
LATUDA and SUNOVION are registered trademarks of Sumitomo Dainippon
Pharma Co., Ltd.
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon
Pharma Co., Ltd. For a copy of this release, visit Sunovion's web site at www.sunovion.com
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