Lunesta (Eszopiclone) Approved by FDA for Treatment of Insomnia

Main Category: Sleep / Sleep Disorders / Insomnia
Article Date: 18 Dec 2004 - 13:00 PDT

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Sepracor Inc (Nasdaq: SEPR) today announced that the US FDA has approved the New Drug Application (NDA) for LUNESTA(TM) brand eszopiclone, formerly referred to as ESTORRA, 1 mg, 2 mg and 3 mg tablets for the treatment of insomnia. 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.

"This novel non-benzodiazepine sleep aid provides a new option for the millions of Americans with chronic insomnia. Unlike all other available prescription sleep aids, which are generally indicated for short-term use, eszopiclone has been studied and approved for use when longer-term treatment is needed," said Andrew Krystal, M.D., Director of the Sleep Disorder Research Laboratory and Insomnia Program at Duke University Medical Center, Durham, NC. "The six-month, double-blind, placebo-controlled study of eszopiclone provides unprecedented evidence of sustained efficacy. There were statistically significant improvements in patient-reported measures of sleep onset and sleep maintenance versus placebo for the entire duration of the study with no evidence of tolerance."

LUNESTA is indicated for the treatment of 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).

"The approval of LUNESTA makes an important treatment option available for patients who have trouble sleeping. Insomnia can include difficulty falling asleep and/or staying asleep. LUNESTA is an important advance for doctors and patients alike, as it can provide sleep efficacy, even over the long term," said Thomas Roth, Ph.D., Director of the Sleep Disorders and Research Center at Henry Ford Hospital, Detroit.

"We are very excited about the commercial launch of LUNESTA, which will take place in early January 2005. Sepracor's sales force, which includes approximately 1,250 sales professionals, is trained and ready to promote LUNESTA to primary care doctors, CNS specialists including psychiatrists, and hospitals in the U.S.," said W. James O'Shea, President and Chief Operating Officer at Sepracor. "We believe that LUNESTA, with its differentiated product label, will provide physicians with a unique treatment option for their insomnia patients, particularly those with sleep maintenance difficulties and those who suffer chronically."

Sepracor continues to study LUNESTA in patients suffering from insomnia. The company also continues to evaluate LUNESTA for the treatment of insomnia in patients suffering from depression or pain, and in women who are experiencing the effects of perimenopause.

"The approval of LUNESTA is an important milestone for Sepracor," said Mark H.N. Corrigan, M.D., Executive Vice President of Research and Development at Sepracor. "The dedication and hard work that led to this tremendous achievement continues, as we are conducting a comprehensive Phase IIIB/IV program for LUNESTA. We will soon complete initial IIIB/IV studies, which include more than 2,000 patients. Treatment of insomnia, as it occurs concomitantly with other conditions, is a significant area of scientific interest, and Sepracor remains committed to the further research of LUNESTA for the treatment of patients with these co-existing conditions."

The LUNESTA NDA contained a total of 24 clinical trials, which included more than 2,700 adult and older adult (ages 65 and older) subjects, and more than 60 preclinical studies. Sepracor conducted six randomized, placebo- controlled Phase III studies for the treatment of chronic or transient insomnia in both adult and older adult patients and included these studies as part of the NDA package, which served as the basis for the FDA's approval of LUNESTA.

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, 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.

Important Safety Information

It is important to note that because sleep disturbances may be caused by underlying physical and/or psychiatric disorders, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7-10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Patients should only take LUNESTA when they are prepared to get a full night of sleep. Until they know how they will react to LUNESTA, patients should not drive or operate machinery.

In conjunction with this press release, Sepracor will host a conference call and live webcast. A replay of the webcast will be archived on the Sepracor web site in the For Investors section.

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. 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 timing of the commercial launch of, and 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: unexpected delays in commercial introduction; 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 quarterly report on Form 10-Q for the quarter ended September 30, 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.

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


"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding Sepracor Inc.'s business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently ended fiscal year.

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