Sepracor advances epilepsy drug - Boston Business Journal:

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The FDA is now formally reviewing the called Stedesa, for final approval. The applicatioj was submitted March 31 as a potential therapy totreaf partial-onset seizures in adults with Partial-onset seizures are the most common form of If approved, the drug woulsd be used in conjunction with other drugs. Adrian Adams, presidenyt and CEO of Sepracor SEPR), said in a prepared statement, “STEDESA represents a significanytand near-term 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 advancingt our pharmaceutical product pipeline.
” Stedesa has been studiede in three Phase III trialx involving more than 1,000 patients from 23 Patients involved in the trials had a historyu of at least four partial-onset seizures per montg despite treatment with one to three anti epileptic drugs. S.A. , a privatelgy held Portuguese pharmaceutical company, was responsible for the researchu and development of thedrug candidate. In, 2007, Sepracotr bought the rights to marketg the drug inthe U.S. and Canada. More than threed million people in the United States livewith epilepsy. The FDA is expectex to make a decision on approval of Stedesaqby Jan. 30.