LunestaTreatment for Insomnia
Sepracor Announces Resubmission of Estorra NDA to FDA
MARLBOROUGH, Mass., June 16, 2004 -- Sepracor Inc. (NASDAQ:SEPR) today announced that it has resubmitted its New Drug Application (NDA) for Estorra brand eszopiclone for the treatment of insomnia to the U.S. Food and Drug Administration (FDA).
On February 27, 2004, Sepracor received an "approvable" letter from the FDA for its NDA for Estorra for the treatment of insomnia characterized by difficulty falling asleep and/or difficulty maintaining sleep during the night and early morning. Contingent upon approval from the FDA of the Estorra NDA, Sepracor would expect the recommended dosing to achieve sleep onset and maintenance to be 2 mg and 3 mg for adult patients, 2 mg for elderly patients with sleep maintenance difficulties, and 1 mg for sleep onset in elderly patients whose primary complaint is difficulty falling asleep. The FDA has not requested additional clinical or preclinical trials for approval.
An NDA that is resubmitted after receipt of an approvable letter is intended to answer all of the questions that need to be addressed prior to approval of the NDA.
Under the Prescription Drug User Fee Act (PDUFA), the FDA has 14 days after resubmission of an NDA to evaluate the submission in order to determine if it is sufficiently complete. If in this 14-day period the FDA determines that the submission is complete, the review clock will be deemed to have restarted as of the date that the resubmission was received by the FDA. During this 14-day review period, the FDA also classifies the resubmission as a Class 1 or Class 2 resubmission. A Class 1 resubmission would involve a two-month FDA review, and a Class 2 resubmission would involve a six-month FDA review. Sepracor expects, based on discussions with the FDA, that the FDA will characterize the resubmission as a Class 2 resubmission.
The NDA contains 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 for the treatment of chronic or transient insomnia were conducted in both adult and elderly patients and were part of the NDA package.
The U.S. market for prescription sleep products, not including off-label use of central nervous system agents not indicated for the treatment of insomnia, was approximately $1.8 billion in 2003.
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. Although the majority of older adults (67%) report frequent sleep problems, only about seven million elderly patients have been diagnosed with sleep problems.
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.
For further information, please visit www.sepracor.com
Posted: June 2004
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- Sepracor Announces Approvable Action for Estorra (eszopiclone) for the Treatment of Insomnia and Provides Update on Launch Plans - March 1, 2004