Lunesta misses Ph II efficacy endpoints

16 March 2009

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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