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Preliminary Results Demonstrate Lunesta Efficacy in Insomnia Patients With Co-Existing Depression

MARLBOROUGH, Mass., Jan. 12 /PRNewswire-FirstCall/ -- Sepracor Inc. (NASDAQ:SEPR) today announced the preliminary results of a Phase IIIB/IV, 545-patient, double-blind, placebo-controlled, ten-week study evaluating the efficacy and safety of LUNESTA(TM) brand eszopiclone in patients with insomnia and co-existing Major Depressive Disorder (MDD).

In this study, patients who met DSM-IV(1) criteria for both insomnia and MDD (either newly diagnosed or patients who have relapsed), were randomized to receive nightly PROZAC(R) brand fluoxetine and either eszopiclone 3 mg (n=270) or placebo (n=275) 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; a sleep maintenance measurement of the amount of time spent awake after initially falling asleep), and total sleep time (TST). Antidepressant efficacy was assessed using HAM- D17 (Hamilton Depression Rating Scale, the standard scale used to assess depression; HAM-D17 is a list of symptoms commonly associated with depression) as well as Clinical Global Impression Improvement (CGI-I) and Severity (CGI-S) scales (used by clinicians to subjectively assess improvement in a patient's symptoms and the severity of their depression, respectively), among other endpoints. Study completion rates were similar in both the placebo- and eszopiclone-treated groups.

Averaged over the double-blind period, patients treated with eszopiclone showed statistically significant (p In this study, eszopiclone co-administered with fluoxetine resulted in statistically significant reductions in overall HAM-D17 scores at week 4 with progressive improvement at week 8, versus the placebo-fluoxetine control group. After removing insomnia-specific questions from HAM-D17, improvements in scores remained significant at week 8. At week 8, significantly more eszopiclone-treated patients were responders (patients experiencing a 50 percent or greater decrease in their HAM-D17 scores) and remitters (patients who have HAM-D17 scores of 7 or lower and are therefore determined to no longer be depressed). CGI-I and CGI-S scores were significantly improved with eszopiclone co-administration.

"Patients suffering from sleep disturbances often have insomnia co- existing with other physical and psychiatric illnesses," said Mark H.N. Corrigan, M.D., Executive Vice President, Research and Development at Sepracor. "Overall, the group that was administered both fluoxetine and eszopiclone did not show worsening of depression as compared with the group that was administered fluoxetine and placebo. In fact, 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. We are encouraged by these results and, after further analysis, anticipate presenting these data to the U.S. Food and Drug Administration (FDA) to discuss how these data may impact future development of LUNESTA."

"The results of this study again demonstrate the efficacy of eszopiclone in the treatment of insomnia symptoms, including sleep onset and sleep maintenance difficulties," said Thomas Roth, Ph.D. of the Henry Ford Sleep Disorder Center in Detroit. "This study underscores the importance of studying LUNESTA as it applies to not only the treatment of insomnia in isolation (primary insomnia), but also how it might be able to help improve symptoms of insomnia that arise in the context of other disorders, such as depression."

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 of 2005.

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 six- month, double-blind, placebo-controlled study in patients with chronic insomnia.

The FDA approved the New Drug Application (NDA) for LUNESTA brand eszopiclone, formerly referred to as ESTORRA, 1 mg, 2 mg and 3 mg tablets for the treatment of insomnia on December 15, 2004. Insomnia can include difficulty falling asleep as well as difficulty maintaining sleep through the night. The recommended dosing to improve sleep onset and/or maintenance is 2 mg or 3 mg for adult patients (ages 18 to 64) and 2 mg for older adult patients (ages 65 and older). The 1 mg dose is for sleep onset in older adult patients whose primary complaint is difficulty falling asleep.

Data from a landmark, long-term (six-month), double-blind, placebo- controlled safety and efficacy study in 788 patients were reviewed by the FDA as part of the NDA submission for eszopiclone and served as a basis for the FDA's decision to not limit LUNESTA's indication to short-term use. Sepracor's six-month study was the first of its kind for a prescription non- benzodiazepine for the treatment of insomnia.

An estimated 100 million adult Americans suffer from either chronic or occasional insomnia.(2) Insomnia can be a serious condition. If left untreated, it may become progressively worse and in turn potentially affect a person's emotional, mental and physical health.

According to the National Institute of Mental Health, depression affects more than 19 million American adults, making it the most common serious mental disorder in the United States. According to the National Institutes of Health (NIH), studies show that insomnia may predispose individuals to depressive illness, regardless of age or gender. According to the National Sleep Foundation's (NSF) 2003 Sleep in America Poll, among adults who have been diagnosed with depression, as many as 70% say that they experience a symptom of insomnia, including difficulty falling asleep, frequent awakenings during the night, awakening too early in the morning, or awakening feeling unrefreshed.

The U.S. market for prescription sleep products, not including off-label (not indicated for the treatment of insomnia) use of central nervous system (CNS) agents for the treatment of insomnia, was approximately $2.1 billion between November 2003 and October 2004, representing a 20 percent increase over the same period the previous year, according to IMS Health information.

Source: Sepracor Inc.

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