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LUNESTA(TM) Second Six-Month Study Data Confirms Findings of First Six-Month Study

Posted on: Monday, 11 April 2005, 09:00 CDT

MARLBOROUGH, Mass., April 11 /PRNewswire-FirstCall/ -- Sepracor Inc. today announced preliminary results from its second six-month, Phase IIIB/IV, randomized, double-blind, placebo-controlled safety and efficacy study of LUNESTA(TM) brand eszopiclone for the treatment of insomnia. The study, which included 828 patients with chronic insomnia, augments the findings in Sepracor's first landmark, six-month study of LUNESTA. This long- term study included a two-week discontinuation phase, which showed no evidence of treatment-related rebound insomnia or withdrawal symptoms.

In this study, nightly use of LUNESTA 3 mg resulted in statistically significant improvement compared with placebo in patient-reported measures of sleep latency (onset of sleep), sleep maintenance, total sleep time and sleep quality (p<0.0001). Patients in this study who were treated with LUNESTA reported improved ability to function (p<0.0001), improved daytime alertness (p<0.0001), improved ability to concentrate (p<0.0001), and improved sense of physical well-being (p<0.0001), versus placebo. These differences were apparent in the first month of treatment and were maintained throughout six months of nightly treatment. LUNESTA was well tolerated over the treatment period.

"This replication of results in the second six-month, double-blind, placebo-controlled study of eszopiclone is noteworthy," said John W. Winkelman, M.D., Ph.D., Associate Director for the Sleep Disorders Program at Brigham and Women's Hospital, Boston. "This study should provide the medical community with confidence in the findings of the first six-month study and raise the bar in examining insomnia agents for long-term use."

Patients 21-64 years of age with chronic insomnia received nightly treatment with either placebo (n=280) or LUNESTA 3 mg (n=548). Efficacy endpoints, including patient-reported sleep latency, total sleep time, sleep maintenance measures (wake time after sleep onset, number of awakenings and number of nights awakened), quality of sleep, as well as next-day ratings of ability to function, daytime alertness, ability to concentrate, and sense of physical well-being, were each evaluated weekly during the double-blind phase.

"The efficacy and safety results of this trial are consistent with the findings of Sepracor's previously published, six-month study of eszopiclone. In both studies, nightly use of eszopiclone provided statistically significant improvements compared with placebo in patient-reported measures of sleep onset and sleep maintenance. In this study, patients treated with eszopiclone demonstrated statistically significant improvements in sleep quality and next- day function," said Thomas Roth, Ph.D., Henry Ford Sleep Disorders Center, Detroit. "Importantly, eszopiclone's efficacy was maintained over the entire six months of treatment, and the discontinuation rate for patients treated with eszopiclone was less than that for patients administered placebo."

On April 4, 2005, Sepracor began full-scale commercial launch of LUNESTA. LUNESTA is now available by prescription in most pharmacies nationwide.

Data from a landmark, long-term (six-month), double-blind, placebo- controlled safety and efficacy study in 788 patients were reviewed by the U.S. Food and Drug Administration (FDA) as part of the New Drug Application (NDA) submission for LUNESTA and served as a basis for the FDA's decision to approve LUNESTA for long-term use. Sepracor's original six-month study was the first of its kind for a prescription non-benzodiazepine for the treatment of insomnia.

LUNESTA is currently indicated for the treatment of insomnia in patients who experience difficulty falling asleep as well as for the treatment of patients who are unable to sleep through the night (sleep maintenance difficulty). With the replication of results of measures of next-day function and sleep quality in this second long-term (six-month) study of LUNESTA, Sepracor plans to review the information with the FDA for potential revision of the product label.

Insomnia can include difficulty falling asleep as well as difficulty maintaining sleep through the night. The recommended dosing for LUNESTA to improve sleep onset and/or maintenance is 2 mg or 3 mg for adult patients (ages 18 to 64). In older adult patients (ages 65 and older), 2 mg is recommended for improving sleep onset and/or maintenance, while the 1 mg dose is recommended for improving sleep onset in older adult patients whose primary complaint is difficulty falling asleep.

An estimated 100 million adult Americans suffer from either chronic or occasional insomnia.(1) 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.

The U.S. market for prescription sleep products was approximately $2.1 billion in 2004, excluding products not indicated for the treatment of insomnia that are nonetheless used in its treatment. This represents nearly a 19 percent increase over the previous year, according to IMS Health information.

Important Safety Information

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. All sleep medicines carry some risk of dependency. Do not use sleep medicines for extended periods without first talking to your doctor. Side effects may include unpleasant taste, headache, drowsiness and dizziness.

Please visit http://www.sepracor.com/ or http://www.lunesta.com/ to access the FDA-approved labeling text for LUNESTA.

About Sepracor

Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease through the discovery, development and commercialization of innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor's drug development program has yielded an extensive portfolio of pharmaceutical compound candidates with a focus on respiratory and central nervous system disorders. The company's commercialization efforts are carried out by its U.S.-based, 1,250-person, primary care and specialty-oriented sales force. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.

This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the commercial launch and availability of LUNESTA brand eszopiclone, as well as the safety, efficacy and potential benefits of LUNESTA. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: unexpected interruptions in commercial distribution of LUNESTA; 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; the ability of the company to attract and retain qualified personnel; and certain other factors that are detailed in the company's annual report on Form 10-K for the year ended December 31, 2004 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.

LUNESTA is a trademark of Sepracor Inc.

(1) Extrapolated to current population from 2000 census based on Ancoli- Israel et al. SLEEP. 1999;22 (suppl 2):S347-S353.

For a copy of this release or any recent release, visit http://www.prnewswire.com/comp/780960.html or http://www.sepracor.com/.

Contacts:

David P. Southwell

Chief Financial Officer

Sepracor Inc.

Jonae R. Barnes

Vice President

Investor Relations

Sepracor Inc.

(508) 481-6700

Sepracor Inc.

CONTACT: David P. Southwell, Chief Financial Officer, or Jonae R.Barnes, Vice President, Investor Relations, both of Sepracor Inc., +1-508-481-6700

Web site: http://www.sepracor.com/

Source: PRNewswire-FirstCall

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