LunestaTreatment for Insomnia
Sepracor Announces Approvable Action for Estorra (eszopiclone) for the Treatment of Insomnia and Provides Update on Launch Plans
MARLBOROUGH, Mass., March 1, 2004 -- Sepracor Inc. (Nasdaq: SEPR) announced that it has received an "approvable" letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Estorra brand eszopiclone 2 mg and 3 mg tablets for the treatment of insomnia characterized by difficulty falling asleep, and/or difficulty maintaining sleep during the night and early morning for adult and elderly patients, and a 1 mg tablet for elderly patients whose primary complaint is difficulty falling asleep. The FDA has not requested additional clinical or preclinical trials for final approval.
The Estorra NDA, which was submitted to the 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.
Pre-launch activities are well underway. Estorra data, including more than 20 abstracts and several oral presentations, will be introduced at upcoming medical society meetings, including the American Psychiatric Association, the Associated Professional Sleep Societies, the American Geriatrics Society, the American Association for Geriatric Psychiatry, the American Academy of Neurology and the American College of Obstetricians and Gynecologists.
Having achieved this pivotal development milestone, Sepracor is now finalizing its commercial launch plans.
"The approvable notification provides the go-ahead to begin the implementation of the final stage of the sales force expansion. This will bring our sales infrastructure to a total of approximately 1,250 sales professionals. It is our intention to have our entire sales force of experienced sales professionals ready for launch by mid-year," said William J. O'Shea, President and Chief Operating Officer of Sepracor Inc.
According to the National Institutes of Health web site, insomnia affects more than 50 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 National Sleep Foundation (NSF) Sleep in America Poll 2003, 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. While only about seven million elderly patients have been diagnosed with sleep problems, the majority of older adults (67%) report frequent sleep problems.
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.
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, including candidates for the treatment of respiratory and central nervous system disorders. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.
Estorra is a trademark of Sepracor Inc.For further information please visit www.sepracor.com
Source: Sepracor Inc.
Posted: March 2004
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