Posted by jrbecker on April 1, 2005, at 9:52:08
In reply to Dexadrine still working; some relapse of depressio » Sarah T., posted by fachad on March 29, 2005, at 23:24:15
http://biz.yahoo.com/prnews/050401/nyf040.html?.v=3
Press Release Source: Sepracor Inc.
Sepracor Announces Launch Timing for LUNESTA(TM) Brand Eszopiclone for Treatment of Insomnia
Friday April 1, 7:00 am ET
MARLBOROUGH, Mass., April 1 /PRNewswire-FirstCall/ -- Sepracor Inc. (Nasdaq: SEPR - News) today announced that the final rule that will designate eszopiclone as a Schedule IV controlled substance will be published in the April 4, 2005 edition of the Federal Register with an immediate effective date. Upon publication of the final rule, Sepracor will commence full-scale commercial launch of LUNESTA(TM) brand eszopiclone. Sepracor expects LUNESTA to be widely available by prescription in pharmacies within days of publication of the rule. At this time, more than 40,000 retail pharmacies have placed orders with wholesalers in anticipation of LUNESTA's launch.
"We are very excited about the commercial launch of LUNESTA. Sepracor's sales force, which includes approximately 1,250 sales professionals, will promote LUNESTA to primary care doctors, psychiatrists and sleep specialists in the U.S.," said W. James O'Shea, President and Chief Operating Officer at Sepracor. "LUNESTA is the first and only sleep medication approved for long- term use, and we believe that, with its extensive clinical program that includes long-term studies, LUNESTA will provide physicians with a unique treatment option for their insomnia patients."The U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for LUNESTA on December 15, 2004. 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 approve LUNESTA for long-term use. Sepracor's six-month study was the first of its kind for a prescription non-benzodiazepine for the treatment of insomnia.
"We are extremely pleased to be able to provide a new prescription sleep aid for the millions of people who have trouble sleeping, particularly those who have difficulty sleeping through the night and those who suffer chronically," said Mark H.N. Corrigan, M.D., Executive Vice President of Research and Development at Sepracor. "LUNESTA is the first non-narcotic non- benzodiazepine with a specific indication in its product label for improving sleep maintenance, and, in clinical studies, treatment with LUNESTA resulted in no measurable next-day residual effects in most patients. With LUNESTA's ability to maintain its efficacy even with long-term, continuous treatment and its lack of significant rebound upon discontinuation of therapy, we believe that LUNESTA provides physicians with an important new treatment option for their patients."
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.
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. 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.
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 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 timing of publication and effectiveness of the rule and of the commercial launch of LUNESTA brand eszopiclone, and 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 delays in publication or effectiveness of the rule and/or commercial introduction 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.
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Source: Sepracor Inc.
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