Sepracor Provides Update On Clinical Trials For SEP-225289, Lunesta

Published: 01-Jul-2009

SEP-225289 did not meet the primary efficacy endpoint, but Lunesta has been proven to be safe and well tolerated

Sepracor has completed the analysis and validation of the preliminary results of a phase II, 514-patient study. It evaluated the efficacy and safety of SEP-225289 for the treatment of Major Depressive Disorder, including patients with melancholic and atypical features.

The company said that SEP-225289 did not meet the primary efficacy endpoint, which was a reduction in symptoms of depression following eight weeks of treatment, as assessed using the clinician-rated, 17-item HAM-D scale.

Mark Corrigan, Executive Vice President, Research and Development at Sepracor, said: “While we are clearly disappointed with the findings from the analysis of the preliminary study results, we are in the process of further analysis of the dose response and secondary endpoints to determine how or if we will take this mechanistic approach forward.”

In 2008 and early 2009, Sepracor has also completed two pediatric studies of Lunesta eszopiclone in response to a written request from FDA, in connection with its efforts to obtain a pediatric exclusivity extension for Lunesta. Lunesta has been proven to be safe and well tolerated, said the company.

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