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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