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FDA will review Stedesa, Sunovion’s epilepsy drug candidate

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 company’s press release.

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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 Sepracor’s 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 Sunovion’s drug application.

Sunovion said it expects the FDA to make a decision about Stedesa/eslicarbazepine acetate later this year.

Eslicarbazepine acetate won approval from European regulators in 2009, where it is marketed under the name of Zebinix by BIAL-Portela & C SA and by BIAL´s licensee, Eisai Europe Limited, Sunovion said. In 2007, Sunovion (then known as Sepracor) acquired the rights from BIAL to further develop and commercialize eslicarbazepine acetate in the US and Canadian markets.

Epilepsy is a neurological disorder that affects nearly 2.2 million people in the United States.

Adequate seizure control of the 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,” Grossman said in his statement.

Sunovion may be best known for its sleep aid Lunesta. In 2011, the company launched Latuda, a treatment of schizophrenia in adults.

Chris Reidy can be reached at
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