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FDA will review Stedesa, Sunovion’s epilepsy drug candidate

Posted: Published on March 1st, 2013

By Chris Reidy, Globe Staff Marlborough drug maker Sunovion Pharmaceuticals Inc. said that US regulators have agreed to review its application to market a potential new treatment for the most common form of epilepsy. The drug candidate is called Stedesa, the proposed trade name for eslicarbazepine acetate, and if approved, it could offer US adults with epilepsy a way to manage partial onset seizures, Sunovion senior vice president Fred Grossman said in a statement included in the companys press release. The company first submitted an application for eslicarbazepine acetate to the US Food and Drug Administration in 2009. The company was still known as Sepracor Inc. then. That same year Sepracor was acquired by the Japanese drug maker Dainippon Sumitomo Pharma Co. Ltd., or DSP, for $2.6 billion. In 2010, DSP changed Sepracors name to Sunovion. In 2010, the FDA asked the company to provide it with additional information about eslicarbazepine acetate, and Sunovion said in a Wednesday press release that it has been informed by the FDA that the agency has sufficient data to review Sunovions drug application. Sunovion said it expects the FDA to make a decision about Stedesa/eslicarbazepine acetate later this year. Eslicarbazepine acetate won approval from … Continue reading

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Sunovion seeks FDA approval for epilepsy drug

Posted: Published on March 1st, 2013

Sunovion Pharmaceuticals Inc. of Marlboro has filed a new application with the U.S. Food and Drug Administration for its experimental epilepsy drug Stedesa. We are pleased to achieve this regulatory milestone for Stedesa, which, if approved, may offer adult patients living with epilepsy an effective, once-daily, adjunctive treatment option for managing partial-onset seizures, said Fred Grossman, senior vice president of clinical development and medical affairs at Sunovion, in a statement. Adequate seizure control of this most common form of epilepsy remains an unmet medical need for a significant number of patients and Sunovion is committed to providing a treatment option to help address this need. The company said the application for Stedesa is supported by data from three clinical trials that included more than 1,300 patients with partial-onset seizures in 35 countries. The most commonly reported adverse events were dizziness, somnolence, headache, nausea, double vision, vomiting, fatigue, ataxia, blurred vision and vertigo, officials added. Sunovion originally sought FDA approval for Stedesa in March 2009. The drug is currently marketed as Zebinix in Europe by licensee Eisai Europe Ltd. See more here: Sunovion seeks FDA approval for epilepsy drug … Continue reading

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Research and Markets: Zebinix ( Epilepsy ) – Forecast and Market Analysis to 2022 with UCB and GlaxoSmithKline Currently …

Posted: Published on March 14th, 2013

DUBLIN--(BUSINESS WIRE)-- Research and Markets (http://www.researchandmarkets.com/research/qq4w5q/zebinix) has announced the addition of GlobalData's new report "Zebinix (Epilepsy) - Forecast and Market Analysis to 2022" to their offering. Zebinix (Epilepsy) - Forecast and Market Analysis to 2022. Epilepsy is a brain disorder characterized by spontaneously occurring and recurrent seizures. The market is heavily driven by the sales of antiepileptic drugs (AEDs) targeted at seizure reduction. The AED market is currently dominated by UCB's Keppra and GlaxoSmithKline's Lamictal. Although both drugs have experienced significant generic erosion, they form the mainstay of epilepsy treatment in the nine markets and will continue to have significant market share during the forecast period. Other key drugs include older generation AEDs such as Pfizer's Dilantin, Abbott's Depakote, and Novartis' Tegretol and Trileptal which still have significant usage due to their longevity in the market. However, the AED dominance landscape will continue to shift towards newer generation drugs particularly following the recent market entry of GlaxoSmithKline's Trobalt/Potiga and Eisai's Fycompa which both offer first-in-class mechanisms of action. Eslicarbazepine acetate (ESL) is a drug developed by Bial - Portela & CA, S.A. that has been approved for marketing in Europe, where it was launched by the company in conjuction with … Continue reading

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