US drugmaker Sepracor's Lunesta (eszopiclone) failed to demonstrate efficacy in a mid-stage trial, assessing the drug for the treatment of generalized anxiety disorder.
The Massachusetts-based firm has completed the analysis and validation of preliminary results from the Phase II, 440-patient study evaluating the efficacy and safety of SEP-225441, a modified-release formulation of eszopiclone.
Sepracor 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-scale used to assess anxiety in clinical trials and consisting of a list of symptoms commonly associated with anxiety.
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