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news.Sepracor has obtained encouraging preliminary results in a phase IIIb/IV study evaluating the efficacy and safety of Lunesta in patients with insomnia and co-existing major depressive disorder.
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In this study, patients who met the relevant criteria (either newly diagnosed or patients who have relapsed) for both insomnia and major depressive disorder (MDD), were randomized to receive nightly Prozac brand fluoxetine (marketed by Eli Lilly) and either Lunesta brand eszopiclone 3mg or placebo for the first eight weeks, followed by a two-week period in which patients discontinued eszopiclone treatment but continued receiving fluoxetine.
Sleep efficacy was assessed using patient-reported measures of sleep onset, wake time after sleep onset (WASO), and total sleep time (TST). Antidepressant efficacy was assessed using Hamilton Depression Rating Scale (HAM)-D17 as well as clinical global impression improvement (CGI-I) and severity (CGI-S) scales, among other endpoints.
Averaged over the double-blind period, patients treated with eszopiclone showed statistically significant improvements in time to sleep onset and in sleep maintenance measures, including WASO and TST, compared to those subjects taking placebo.
In this study, eszopiclone co-administered with fluoxetine resulted in statistically significant reductions in overall HAM-D17 scores at week four with progressive improvement at week eight, versus the placebo-fluoxetine control group.
After removing insomnia-specific questions from HAM-D17, improvements in scores remained significant at week eight. At week eight, significantly more eszopiclone-treated patients were responders (patients experiencing a 50% or greater decrease in their HAM-D17 scores) and remitters (patients who have HAM-D17 scores of seven or lower and are therefore determined to no longer be depressed). CGI-I and CGI-S scores were significantly improved with eszopiclone co-administration.
“Based on the preliminary results of this study, it appears that the combination of eszopiclone and fluoxetine resulted in greater improvement in HAM-D17 scores in patients with MDD and insomnia than was observed in the placebo-fluoxetine control group,” said Dr Mark Corrigan, executive vice president of R&D at Sepracor.
“We are encouraged by these results and, after further analysis, anticipate presenting these data to the FDA to discuss how these data may impact future development of Lunesta.”
Sepracor has submitted results of this study to be considered by the American Psychiatric Association and the Associated Professional Sleep Societies for presentation at their respective scientific meetings in May and June.
Additional phase IIIb/IV studies of Lunesta are nearing completion. These studies include the evaluation of Lunesta for the treatment of insomnia in women experiencing the hormonal changes associated with perimenopause, in patients experiencing pain associated with rheumatoid arthritis, and a study in patients with chronic insomnia.