June 1, 2009
Sepracor Drug Under FDA Review
By Christina Davis
A new seizure medication under development by Marlborough-based Sepracor Inc. is now under formal review by the U.S. Food and Drug Administration.
Sepracor submitted a new drug application for the drug, called Stedesa, on March 31. The drug is being developed as a treatment of "partial-onset seizures in adult with epilepsy."
Stedesa has been studied in three Phase III trials, which involved more than 1,000 patients from 23 countries.
The research and development on the drug was done by BIAL-Portela & CA of Portugal. Sepracor acquired the rights to commercialize the drug in the United States and Canada in late 2007.
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