MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) will present new research posters on Aptiom® (eslicarbazepine acetate) and data on antiepileptic drug (AED) use in the U.S. managed care population at the 67th Annual Meeting of the American Epilepsy Society (AES) taking place December 6-10 in Washington, D.C.
Key data presented will include pivotal Phase 3 study results that supported the recent U.S. Food and Drug Administration (FDA) approval of APTIOM on November 8, 2013 for use as adjunctive treatment of partial-onset seizures, as well as results from two Phase 3 studies that investigated the efficacy and safety of APTIOM as monotherapy treatment for partial-onset seizures in adults. The efficacy and safety of APTIOM as monotherapy treatment for patients with partial-onset seizures has not been evaluated by the FDA. APTIOM is not approved for use as monotherapy.
“Sunovion is committed to innovative science that helps both uncover and address unmet needs of people living with epilepsy,” said Fred Grossman, D.O., FAPA, Senior Vice President, Clinical Development and Medical Affairs at Sunovion. “Advancing science is at the core of everything we do, and sharing research with the healthcare practitioners dedicated to caring for patients living with epilepsy is part of our ongoing commitment to improving the lives of patients.”
Scientific data from Sunovion slated for presentation at AES, which is taking place December 6-10, 2013 in Washington D.C., include:
Poster Session 1: Saturday, December 7, 2013, from 12:00 p.m. EST until 6:00 p.m. EST
- Abstract 1.209 - Eslicarbazepine Acetate Is Antiepileptogenic in the Pilocarpine Mouse Model of Temporal Lobe Epilepsy
- Abstract 1.228 - Conversion to Monotherapy with Eslicarbazepine Acetate in Adults with Partial-Onset Seizures
Poster Session 2: Sunday, December 8, 2013, from 8:00 a.m. EST until 5:00 p.m. EST
- Abstract 2.126 - Eslicarbazepine Acetate as Adjunctive Treatment for Refractory Partial-Onset Seizures: Pooled Analysis of Safety Data from Three Phase III Controlled Trials
- Abstract 2.127 - Efficacy of Eslicarbazepine Acetate in Patients with Refractory Partial-Onset Seizures: A Pooled Analysis of Three Phase III Controlled Studies
- Abstract 2.128 - Eslicarbazepine Acetate as Adjunctive Therapy in Patients with Refractory Partial-Onset Seizures: Safety Results of a 12-Week Randomized Placebo-Controlled Study
- Abstract 2.137 - Resource Utilization Among Epilepsy Patients with and without Breakthrough Seizures in a U.S. Managed Care Population
- Abstract 2.230 - Healthcare Utilization Among Patients with Uncontrolled Epilepsy: A Retrospective Study in a Commercially-Insured U.S. Population
Poster Session 3: Monday, December 9, 2013, from 8:00 a.m. EST until 3:30 p.m. EST
- Abstract 3.210 - Adjunctive Eslicarbazepine Acetate in Patients with Refractory Partial-Onset Seizures: Efficacy Results of a 12 Week Randomized Placebo-Controlled Study
About Partial-Onset Seizures
Epilepsy is characterized by abnormal firing of impulses from nerve cells in the brain.i 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.ii, iii 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.iv Reducing the frequency of seizures can greatly lessen the burden of epilepsy.iv With approximately one-third of people living with epilepsy still unable to control seizures, there continues to be a need for new therapies.v
About APTIOM
APTIOM, a voltage-gated sodium channel inhibitor, is a prescription medicine approved for use as adjunctive treatment of partial-onset seizures.
The initial research and development of eslicarbazepine acetate was performed by BIAL-Portela & Ca, 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 Canadian markets from BIAL. BIAL gained approval for eslicarbazepine acetate from the European Commission on April 21, 2009 as adjunctive therapy in adult patients with partial-onset seizures with or without secondary generalization and it is currently marketed in Europe under the trade name Zebinix®.
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. 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 area and 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 about 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.
i National Institutes of Health. “NINDS Epilepsy Information
Page” Accessed 5 September 2013. <http://www.ninds.nih.gov/disorders/epilepsy/epilepsy.htm>
ii
Epilepsy Foundation. “Partial Seizures.” Accessed 5 September 2013. <“http://www.epilepsyfoundation.org/aboutepilepsy/seizures/partialseizures/index.cfm>
iii
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>
iv
IOM (Institute of Medicine). 2012. Epilepsy across the spectrum:
Promoting health and understanding. Washington, DC: The National
Academies Press.
v Brodie MJ, Barry SJE, Bamagous GA,
Norrie JD, Kwan P. Patterns of treatment response in newly diagnosed
epilepsy. Neurology. 2012;78:1548-1554.
