indiplon versus estorra

SAN DIEGO, October 19, 2004 -- Neurocrine Biosciences, Inc indiplon versus estorra. (NASDAQ:NBIX) announcedthat it has submitted a New Drug Application (NDA) to the U.S indiplon versus estorra. Food and DrugAdministration (FDA) for regulatory approval of indiplon immediate release capsulesfor the treatment of insomnia indiplon versus estorra. The application contains safety and efficacyresults from seven Phase III clinical trials with indiplon immediate releaseconducted in adult and elderly patients with transient and chronic insomnia indiplon versus estorra. Neurocrine is developing two formulations of indiplon, an immediate releasecapsule and modified release tablet, for the treatment of multiple forms ofinsomnia indiplon versus estorra. Neurocrine expects to submit a second NDA for indiplon modified releasetablets in November indiplon versus estorra. This first NDA submission contains non-clinical, clinicaland manufacturing information that is common to both applications.

The NDA has been submitted in electronic common technical document format (e-CTD) indiplon versus estorra. It includes data from a comprehensive safety and efficacy evaluation in approximately3000 subjects.

"Insomnia affects over 85 million younger and older adults every yearand is becoming more recognized by physicians as a disease that affects manyaspects of patients' health and well-being indiplon versus estorra. Insomnia is not a one size fitsall condition as patients experience various types of sleep difficulties andsymptoms such as trouble falling asleep, trouble staying asleep or waking upfrequently during the night indiplon versus estorra. Indiplon capsules and tablets have consistentlydemonstrated robust efficacy and safety in repeated clinical evaluations, measuringmultiple parameters of sleep difficulties indiplon versus estorra. These results confirm that indiplonwill offer physicians a significant improvement in the diagnosis and treatmentof patients' individual sleep needs," said Dr indiplon versus estorra. Thomas Roth, Director SleepDisorders Center, Henry Ford Hospital.

"The submission of the indiplon NDA is a significant milestone for Neurocrine,the first in the Company's history indiplon versus estorra. Indiplon is an important advancement inthe treatment of insomnia as it was specifically designed and developed to addressthe individual sleep needs of patients indiplon versus estorra. Indiplon capsules have consistentlydemonstrated that patients fall asleep faster, have improved sleep quality andsleep duration indiplon versus estorra. Phase III safety and efficacy clinical trials have shown thatindiplon capsules can be taken during the night for patients who suffer fromnighttime awakenings and have been shown to be safe and effective for long termchronic usage indiplon versus estorra. We are pleased to have Pfizer, the leading global pharmaceuticalcompany, as our partner in the development and commercialization of indiplon,"said Gary A indiplon versus estorra. Lyons, President and CEO of Neurocrine Biosciences.

About Indiplon
Indiplon is a unique non-benzodiazapine agent that acts on a specific site ofthe GABA-A receptor indiplon versus estorra. Indiplon has been shown to bind selectively to the specificsubtype of GABA-A receptors within the brain believed to be responsible forpromoting sleep indiplon versus estorra. Two formulations of indiplon, immediate release capsules andmodified release tablets, are being evaluated in clinical trials to addressdifferent types of sleep problems indiplon versus estorra. Indiplon was licensed from DOV Pharmaceuticalin 1998.

Insomnia is a prevalent condition in the United States, with approximately40 percent of the adult population reporting trouble sleeping a few nights perweek or more, according to the National Sleep Foundation's (NSF) Sleep in AmericaPoll 2002 indiplon versus estorra. Approximately 35 percent of the adult population reports that theyhave experienced insomnia every night or almost every night within the pastyear indiplon versus estorra. Insomnia remains a disorder with high unmet medical needs, including prolongedawakenings during the night with difficulty falling back to sleep.

Neurocrine Biosciences, Inc indiplon versus estorra. is a product-based biopharmaceutical company focusedon neurological and endocrine diseases and disorders indiplon versus estorra. Our product candidatesaddress some of the largest pharmaceutical markets in the world including insomnia,anxiety, depression, diabetes, multiple sclerosis, irritable bowel syndrome,eating disorders, pain, and autoimmunity indiplon versus estorra. Neurocrine Biosciences, Inc indiplon versus estorra. newsreleases are available through the Company's website via the Internet at www.neurocrine.com.

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