Sepracor Announces Presentation of LUNESTA™ Posters at Associated Professional Sleep Societies Annual Meeting

Business Wire, June 21, 2006

MARLBOROUGH, Mass. -- Sepracor Inc. (Nasdaq: SEPR) today announced that data for LUNESTA(TM) brand eszopiclone for the treatment of insomnia were presented at the SLEEP 2006 20th Anniversary Meeting of the Associated Professional Sleep Societies in Salt Lake City. The data included four poster presentations of results from LUNESTA Phase IIIB/IV studies.

Two Double-Blind, Placebo-Controlled, 6-Month Trials of Eszopiclone for Insomnia: Pooled Analysis by Race/Ethnicity

Results of two similar six-month, double-blind, placebo-controlled studies of LUNESTA 3 mg for the treatment of insomnia were pooled and analyzed by stratifying by race/ethnicity for 1,581 patients. The analysis examined patient response to LUNESTA across various sleep parameters including sleep latency (time to sleep onset), wake time after sleep onset (WASO, a measure of sleep maintenance), total sleep time (TST), daytime alertness, ability to function and sense of physical well-being. In this analysis, Caucasians (n=1,195) and African-Americans (n=236) who were administered LUNESTA achieved statistically significant (p<0.05) improvements across each measurement of sleep and next-day function over the treatment period versus those patients administered placebo. Among Hispanic patients (n=150), improvements across all sleep and next-day function parameters were observed versus placebo, but these differences were not statistically significant, likely due to the small number of patients in this cohort.

Analysis of Individual Items of the Hamilton Depression Scale in a Study of Eszopiclone/Fluoxetine Co-Therapy

A post-hoc analysis based on an 8-week, randomized, double-blind, placebo-controlled, 545-patient study of LUNESTA in combination with fluoxetine in the treatment of patients with insomnia and co-existing Major Depressive Disorder (MDD) were presented. In the study, depression was evaluated using the Hamilton Depression Rating Scale, or HAM-D17, which is a list of 17 items commonly associated with depression. This analysis examined the three insomnia items of the HAM-D17 scale to determine the impact of LUNESTA-fluoxetine therapy on these scores. This analysis also examined each of the other 14 components of the HAM-D17 to determine the extent that, compared to fluoxetine-placebo, reductions in HAM-D17 in the LUNESTA-fluoxetine treatment group were attributable only to reductions in the sleep items included in the HAM-D17. In the study, patients in the LUNESTA-fluoxetine treatment group demonstrated statistically significant (p<0.05) improvements in all three insomnia items of the HAM-D17 versus the placebo-fluoxetine treatment group at Weeks 4 and 8.

At Week 8, significantly greater improvements were noted in the total score (p=0.0015), the three insomnia items (p<0.05), guilt (p<0.05), and work/activities (p<0.05) for patients treated in the LUNESTA-fluoxetine group relative to the fluoxetine-placebo group. Further, statistically significant (p<0.05) reductions from baseline were observed in the LUNESTA-fluoxetine group compared to the fluoxetine-placebo group at Week 10 for the total score and for the following symptoms: insomnia early, middle and late; retardation; feeling of guilt; agitation; psychic anxiety; work and activities; general somatic symptoms; and hypochondriasis.

The results of this post-hoc analysis do not establish safety or efficacy of LUNESTA as either a primary or adjunctive therapy for the treatment of depression. LUNESTA is indicated for the treatment of insomnia. LUNESTA is not indicated for the treatment of depression. Sedative hypnotics should be administered with caution to patients exhibiting signs and symptoms of depression.

Eszopiclone Co-Administered with Fluoxetine for Insomnia Co-Existing with Major Depressive Disorder (MDD): Analysis by Severity of Insomnia

Another post-hoc analysis of the results of the 8-week study of LUNESTA in combination with fluoxetine was presented. In this analysis, patients' insomnia severity was assessed and stratified based on their baseline Insomnia Severity Index (ISI) scores; moderate insomnia was defined as a total ISI score of less than 18, severe insomnia was defined as a total ISI score greater than or equal to 18. Changes in TST, WASO, sleep latency and HAM-D17 were then assessed for each severity group. Magnitude of improvement in insomnia symptoms was dependent on baseline insomnia severity for both the placebo-fluoxetine and LUNESTA-fluoxetine treatment groups, with patients with more severe baseline insomnia exhibiting greater changes in insomnia symptoms with treatment. Magnitude of reduction in HAM-D17 scores was generally not related to baseline insomnia severity for either treatment group. Patients in the LUNESTA-fluoxetine treatment group showed statistically significantly greater improvement (p<0.05) in TST, WASO and sleep latency at most time points compared with patients in the placebo-fluoxetine group, regardless of severity. Patients in the LUNESTA-fluoxetine treatment group also demonstrated greater reduction in HAM-D17 scores than those in the placebo-fluoxetine group, and a greater percentage of LUNESTA-fluoxetine patients were responders (50% or greater reduction from baseline in HAM-D17 scores) and remitters (HAM-D17 scores of less than or equal to 7) compared with patients in the fluoxetine-placebo group, regardless of insomnia severity.