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Sunovion to Present Data on Aptiom® (eslicarbazepine acetate) at the American Epilepsy Society (AES) Annual Meeting 2017Sunovion Pharmaceuticals Inc. (Sunovion) will present nine posters on Aptiom® (eslicarbazepine acetate) at the American Epilepsy Society (AES) Annual Meeting 2017, taking place December 1-5, 2017, in Washington, D.C. APTIOM is a once-daily, immediate release antiepileptic drug (AED) that is approved in the U.S. for the treatment of partial-onset seizures (POS) in individuals four years of age and older. Sunovion recently received approval in the U.S. to expand the indication for APTIOM to include treatment of POS in adolescents and children four to 17 years of age. "Epilepsy is one of the most common neurological conditions in the U.S., affecting approximately 3.4 million people, including an estimated 470,000 children and adolescents," said David Blum, M.D., Global Head, Neurology Clinical Research at Sunovion. "Sunovion's presentations of APTIOM data at AES underscore our continued commitment to the epilepsy community and to furthering the understanding of the treatment of partial-onset seizures." Sunovion presentations at AES 2017 include:
About Aptiom® (eslicarbazepine acetate) The initial research and development of eslicarbazepine acetate was performed by BIAL, a privately held Portuguese research-based pharmaceutical company. Sunovion acquired the rights to eslicarbazepine acetate in the United States and Canada markets under an exclusive license from BIAL. APTIOM is approved in Canada for use as adjunctive therapy in the treatment of partial-onset seizures in adults 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; in December 2016, as adjunctive treatment for patients above six years of age with partial-onset seizures with or without secondary generalization; and in March 2017, as monotherapy in the treatment of partial-onset seizures, with or without secondary generalization, in adults with newly diagnosed epilepsy. 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: Do not take APTIOM if you are allergic to eslicarbazepine acetate, any of the other ingredients in APTIOM, or oxcarbazepine. 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.
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, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the company's websites: 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. BROVANA is a registered trademark of Sunovion Pharmaceuticals Inc. APTIOM is a registered trademark of BIAL, used under license. SEEBRI and UTIBRON are trademarks of Novartis AG, used under license. NEOHALER is a registered trademark of Novartis AG, used under license. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd. © 2017 Sunovion Pharmaceuticals Inc. All rights reserved. For a copy of this release, visit Sunovion's web site at www.sunovion.com References
1 Institute of Medicine (IOM). 2012. "Epilepsy across the
spectrum: Promoting health and understanding." Washington, DC: The
National Academies Press.
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