Healthcare Industry News: LUNESTA
News Release - October 12, 2006
Newly Published Data Show Efficacy and Safety of LUNESTA(R) in Elderly Patients with Insomnia
Data Showed Improvements in Both Polysomnographic and Patient-Reported Sleep MeasuresMARLBOROUGH, Mass.--(HSMN NewsFeed)--Sepracor Inc. (Nasdaq: SEPR ) today announced the publication of results of a large, randomized, double-blind, placebo-controlled, two-week study of LUNESTA® brand of eszopiclone for the treatment of insomnia in elderly patients. The study was conducted in 49 centers across the U.S. and included elderly patients (64-86 years of age; n=264) who met DSM-IV® (1) criteria for primary insomnia and screening polysomnographic (PSG; a type of study conducted in a sleep laboratory) criteria. Patients were randomized to two weeks of nightly treatment with either LUNESTA 2 mg or placebo. Efficacy and safety were assessed at overnight sleep laboratory visits using PSG measures and Interactive Voice Response System (IVRS) morning and evening questionnaires, and through patient-reported IVRS morning and evening questionnaires at home. The results were published in the September 2006 edition of the journal, Current Medical Research and Opinion.
The study showed that elderly patients with chronic primary insomnia who were administered LUNESTA 2 mg experienced significant (p less than 0.05) improvements in measures of sleep maintenance (ability to sleep through the night), sleep induction (time to fall asleep) and sleep duration (total sleep time), as assessed by both PSG objective measurements and patient-reported subjective measures, versus those patients administered placebo.
"Chronic insomnia is a serious condition that is more prevalent in elderly adults than in the general population. However, due to the comparatively limited number of studies that have been performed in elderly patients, there is very little patient-reported or PSG data examining the effectiveness of sleep aids in older adults," said W. Vaughn McCall, director of the sleep laboratory at Wake Forest University Baptist Medical Center and professor and chairman of the Department of Psychiatry and Behavioral Medicine, Winston-Salem, NC. "The most frequently reported sleep complaint among elderly patients is the inability to maintain sleep through the night. The data from this recent study of LUNESTA are clinically relevant as they show that elderly patients treated with LUNESTA demonstrated improvements in sleep maintenance."
Study data showed that LUNESTA 2 mg was associated with a significantly (p less than 0.05) reduced time to sleep onset, reduced wake time after sleep onset (WASO), increased sleep efficiency and increased total sleep time (TST). In this study, LUNESTA was generally well tolerated with the most frequently reported adverse events being pain, dry mouth, dizziness, somnolence and unpleasant taste.
"This study is the largest-ever published, placebo-controlled, double-blind clinical trial of nightly administration of a sleep agent in elderly patients with chronic insomnia using both PSG and patient-reported measures," said McCall. "These data underscore the value of conducting future, longer-term studies of LUNESTA in elderly patients suffering from chronic insomnia, and in those who experience insomnia due to co-existing conditions common to this population, such as depression or arthritis."
The results from this study were consistent with findings from a previously published, two-week trial in the journal SLEEP, which studied the administration of LUNESTA 1 mg and 2 mg in elderly patients with insomnia outside of a sleep lab environment.(2)
To access the study published in Current Medical Research and Opinion, please visit: http://libra.publisher.ingentaconnect.com/content/libra/cmro /2006/00000022/00000009/art00002
(Due to the length of this URL, it may be necessary to copy and paste it into your Internet browser's URL address field. You may also need to remove an extra space in the URL if one exists.)
About LUNESTA
LUNESTA is indicated for the treatment of insomnia in patients 18 years of age and older who are experiencing difficulty falling asleep and/or maintaining sleep through the night. LUNESTA is available in 1 mg, 2 mg and 3 mg tablets and treatment should be individualized based on patient age, history and insomnia symptoms. LUNESTA is a Schedule IV controlled substance.
Important Safety Information
LUNESTA is indicated for the treatment of insomnia. LUNESTA works quickly and should only be taken immediately before bedtime. Be sure you have at least eight hours to devote to sleep before becoming active. You should not engage in any activity after taking LUNESTA that requires complete alertness, such as driving a car or operating machinery. You should use extreme care when engaging in these activities the morning after taking LUNESTA. Do not use alcohol while taking any sleep medicine. Most sleep medicines carry some risk of dependency. Do not use sleep medicines for extended periods without first talking to your doctor. Please see your doctor if you experience unusual changes in thinking or behavior, or your sleep problems do not improve in 7 to 10 days as this may be due to another medical condition. Side effects may include unpleasant taste, headache, drowsiness and dizziness.
About Sepracor
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor's drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.
Forward-Looking Statement
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy and potential benefits of LUNESTA brand eszopiclone. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: Sepracor's ability to fund, and the results of, further clinical trials; the timing and success of submission, acceptance, and approval of additional regulatory filings; the scope of Sepracor's patents and the patents of others; the commercial success of LUNESTA; any changes in the use and/or label of LUNESTA; the ability of the company to attract and retain qualified personnel; and certain other factors that are detailed in the company's quarterly report on Form 10-Q for the quarter ended June 30, 2006 filed with the Securities and Exchange Commission.
In addition, the statements in this press release represent Sepracor's expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor's expectations or beliefs as of any date subsequent to the date of this press release.
(1) Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition
(2) Scharf M, Erman M, Rosenberg R, et al. A two-week efficacy and safety study of eszopiclone in elderly patients with primary insomnia. SLEEP 2005;28:720-7
LUNESTA is a registered trademark of Sepracor Inc. DSM-IV is a registered trademark of the American Psychiatric Association.
For a copy of this release or any recent release, visit Sepracor's web site at www.sepracor.com.
Source: Sepracor
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