Sepracor reports preliminary Ph II SEP-225441 results in GAD

16 March 2009

USA firm Sepracor has completed the analysis and validation of the preliminary results of a Phase II, 440-patient study evaluating the  efficacy and safety of SEP-225441, a modified-release formulation of  eszopiclone for the treatment of generalized anxiety disorder. The  company  determined that the study did not meet its primary efficacy  endpoint, which was reduction in symptoms of GAD, as assessed using the  clinician-rated Hamilton Anxiety Rating Scale, a standard used to assess  anxiety in clinical trials and consisting of a list of symptoms commonly  associated with anxiety.

"While we are disappointed with the preliminary analysis of the study  results, we are in the process of further analyzing the data in an  effort to determine whether any of the secondary endpoints were met and  whether this compound warrants further clinical development," said Mark  Corrigan, executive vice president, R&D, of Sepracor.

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