Sepracor says Lunesta may relieve symptoms in major depressive disorder

By Elaine Rigoli

Tampa, Fla., April 4 - Sepracor, Inc. released data from its phase 3b/4, 545-patient study of Lunesta brand eszopiclone in patients with insomnia and co-existing major depressive disorder (MDD).

This double-blind, placebo-controlled, 10-week study evaluated the efficacy and safety of Lunesta in patients who met DSM-IV criteria for both insomnia and MDD (either newly diagnosed or patients who have relapsed with MDD).

Patients were randomized to receive open-label Prozac brand fluoxetine each morning and either double-blind Lunesta 3 mg or a placebo nightly for the first eight weeks, followed by a two-week period during which patients discontinued double-blind treatment and continued receiving fluoxetine.

Throughout the double-blind treatment period, patients treated with Lunesta showed improvements in time to sleep onset and total sleep time, compared to those patients taking a placebo, according to a news release.

This study also monitored antidepressant efficacy using clinical global impression improvement (CGI-I) and severity (CGI-S) scales, which are used by clinicians to assess improvement in a patient's MDD symptoms and the severity of their depression at various time points, respectively.

Participants demonstrated shorter times to antidepressant response based on CGI-I and CGI-S as compared to the placebo-fluoxetine group, the release said.

Fewer patients in the Lunesta-fluoxetine group (44.7%) required titration to a higher dose of fluoxetine as compared to those in the placebo-fluoxetine control group (53.7%).

The Lunesta-fluoxetine treatment group did not show a worsening of depression as compared to the placebo-fluoxetine group, and the Lunesta-fluoxetine combination appeared to result in greater improvement than the placebo-fluoxetine group, the release said.

There were no significant differences between the treatment groups at any assessment point and there were no significant differences in the 30% antidepressant response or time to onset of a 30% response with patient-reported Bech and Maier subscales.

However, clinician-rated versions of the Bech and Maier subscales were improved in the Lunesta-fluoxetine treatment group at both assessment points during the double-blind period.

Sepracor is a research-based pharmaceutical company located in Marlborough, Mass.

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