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Eszopiclone Phase IIIb Insomnia Studies Underway

MARLBOROUGH, Mass., Dec. 18 /PRNewswire-FirstCall/ -- Sepracor Inc. today announced that it has initiated Phase IIIB studies for ESTORRA™ brand eszopiclone. These studies are designed to evaluate eszopiclone in the treatment of insomnia in patients suffering from depression, in patients with rheumatoid arthritis (RA) and in women who experience symptoms of perimenopause.

The Phase IIIB clinical program for ESTORRA includes: -- A double-blind, placebo-controlled, 8-week study for the treatment of insomnia in patients suffering from depression, with a target enrollment of 600 patients; -- A double-blind, placebo-controlled, 4-week study for the treatment of insomnia in patients suffering from RA, with a target enrollment of 440 patients; -- A double-blind, placebo-controlled, 4-week study for the treatment of insomnia in women experiencing perimenopause, with a target enrollment of 440 patients; and -- A double-blind, placebo-controlled, 6-month safety and efficacy study for the treatment of chronic insomnia, with a target enrollment of 800 patients at 70 sites in the U.S. This study began in October 2003.

These studies are being conducted on Sepracor's initiative to provide further clinical information on the effects of ESTORRA in the treatment of insomnia in these patient populations.

"Patients suffering from sleep disturbances often have insomnia secondary to other physical and psychiatric illnesses or disease as well as with the occurrence of perimenopause," said Mark H.N. Corrigan, M.D., Executive Vice President, Research and Development at Sepracor. "We are committed to exploring these areas in sleep research that, until now, have been inadequately studied, despite the profound impact that insomnia has on individuals suffering from these common conditions. Our hope is that these studies may provide us with a much better understanding of how sleep improvements can positively impact the lives of patients with depression or rheumatoid arthritis, and women going through the endocrine changes of menopause."

Depression -- 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. Studies have been conducted that show that insomnia may predispose individuals to depressive illness, regardless of age or gender, according to the National Institutes of Health (NIH). Symptoms of depression include a persistent sad mood; loss of interest or pleasure in activities that were once enjoyed; significant change in appetite or body weight; difficulty sleeping or oversleeping; physical slowing or agitation; loss of energy; feelings of worthlessness or inappropriate guilt; difficulty thinking or concentrating; and recurrent thoughts of death or suicide. 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.

Rheumatoid Arthritis and Pain -- Rheumatoid arthritis is an inflammatory disease that causes pain, swelling, stiffness, and loss of function in the joints. It has several characteristics that make it different from other kinds of arthritis. RA generally occurs in a symmetrical pattern. This means that if one knee or hand is involved, the other one is, too. The disease often affects the small joints of the wrist and hand. It can also affect other joints such as the neck, shoulders, elbows, hips, knees, ankles, and feet. As a systemic disease, it can also affect other tissues, such as blood cells and lungs. As a result, people with the disease may experience fatigue, occasional fever, and a general sense of not feeling well. Daily joint pain is an inevitable consequence of the disease, and most patients also experience some degree of depression, anxiety, and feelings of helplessness. According to the NSF, among those suffering from rheumatic or arthritic disorders, as many as 75% often suffer from sleep problems. People suffering from RA frequently experience disturbed sleep, awakenings during the night, as well as a decrease in energy, weakness and function.

Perimenopause -- According to a 1998 poll conducted by the NSF, 40-50 million women in America are menopausal. Perimenopause in women occurs at the time period surrounding and including menopause, when the body begins to undergo both physical and hormonal changes. Perimenopause can last just a few months or as long as several years and may begin as early as age 35. Difficulty sleeping and the resulting fatigue may occur due to waking up in the middle of the night because of night sweats, which are also known as hot flashes. This can lead to trouble falling back to sleep. Perimenopausal women may also experience difficulty falling asleep or awakening early in the morning during this reproductive change.

The ESTORRA New Drug Application (NDA), which was submitted to the U.S. Food and Drug Administration (FDA) on January 31, 2003, contained a total of 24 clinical trials, which included more than 2,700 adult and elderly subjects, and more than 60 preclinical studies. A total of six randomized, placebo- controlled Phase III studies, including one with a positive control, for the treatment of chronic or transient insomnia were conducted in both adult and elderly patients and were part of the NDA package. In a recent communication from the FDA, Sepracor was informed that the FDA anticipates completion of its review of the ESTORRA brand eszopiclone NDA on or before February 29, 2004.

According to the NIH web site, insomnia affects more than 70 million Americans. Symptoms of insomnia include difficulty falling asleep, awakening frequently during the night, waking up too early, an inability to fall back to sleep, or awakening feeling unrefreshed.

According to the NSF's 2003 Sleep in America Poll, 37 million older Americans suffer from frequent sleep problems that, if ignored, can complicate the treatment of several other medical conditions, from arthritis to diabetes, heart and lung disease and depression. This NSF poll shows that poor sleep among older adults often goes unnoticed by the medical community. Although the majority of older adults (67%) report frequent sleep problems, only about seven million elderly patients have been diagnosed.

The U.S. market for prescription sleep products, not including off-label (not indicated for the treatment of insomnia) use of central nervous system agents for the treatment of insomnia, was approximately $1.5 billion in 2002. The U.S. prescription sleep agent market grew at a rate of almost 25 percent for the past two years, according to IMS Health information.

Source: Sepracor Inc.

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