Sepracor advances epilepsy drug - Boston Business Journal:

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The FDA is now formally reviewing the called Stedesa, for final The application was submitted March 31 as a potential therapy to treat partial-onset seizures in adults with epilepsy. Partial-onsegt seizures are the most commomn formof epilepsy. If the drug would be used in conjunctiom withother drugs. Adrian president and CEO of Sepracor (Nasdaq: SEPR), said in a prepared “STEDESA represents a significantand near-ter opportunity for Sepracor, and the FDA acceptancre of the NDA is yet another step forward in one of our near-- and mid-term corporate objectives of expanding and advancingy our pharmaceutical product pipeline.
” Stedesa has been studieed in three Phase III trials involving more than 1,000 patient from 23 countries. Patients involved in the triald had a history of at leastfour partial-onset seizuresx per month despite treatment with one to three anti epilepticf drugs. S.A. , a privately held Portuguesr pharmaceutical company, was responsible for the researchn and development of thedrug candidate. In, 2007, Sepraco r bought the rights to market the drug inthe U.S. and More than three million people in the Unite d States livewith epilepsy. The FDA is expected to make a decisiomn on approval of Stedesaby Jan. 30.