indiplon buy online cheap

SAN DIEGO, October 19, 2004 -- Neurocrine Biosciences, Inc indiplon buy online cheap. (NASDAQ:NBIX) announcedthat it has submitted a New Drug Application (NDA) to the U.S indiplon buy online cheap. Food and DrugAdministration (FDA) for regulatory approval of indiplon immediate release capsulesfor the treatment of insomnia indiplon buy online cheap. 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 buy online cheap. Neurocrine is developing two formulations of indiplon, an immediate releasecapsule and modified release tablet, for the treatment of multiple forms ofinsomnia indiplon buy online cheap. Neurocrine expects to submit a second NDA for indiplon modified releasetablets in November indiplon buy online cheap. 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 buy online cheap. 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 buy online cheap. 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 buy online cheap. Indiplon capsules and tablets have consistentlydemonstrated robust efficacy and safety in repeated clinical evaluations, measuringmultiple parameters of sleep difficulties indiplon buy online cheap. These results confirm that indiplonwill offer physicians a significant improvement in the diagnosis and treatmentof patients' individual sleep needs," said Dr indiplon buy online cheap. 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 buy online cheap. Indiplon is an important advancement inthe treatment of insomnia as it was specifically designed and developed to addressthe individual sleep needs of patients indiplon buy online cheap. Indiplon capsules have consistentlydemonstrated that patients fall asleep faster, have improved sleep quality andsleep duration indiplon buy online cheap. 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 buy online cheap. We are pleased to have Pfizer, the leading global pharmaceuticalcompany, as our partner in the development and commercialization of indiplon,"said Gary A indiplon buy online cheap. 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 buy online cheap. Indiplon has been shown to bind selectively to the specificsubtype of GABA-A receptors within the brain believed to be responsible forpromoting sleep indiplon buy online cheap. Two formulations of indiplon, immediate release capsules andmodified release tablets, are being evaluated in clinical trials to addressdifferent types of sleep problems indiplon buy online cheap. 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 buy online cheap. Approximately 35 percent of the adult population reports that theyhave experienced insomnia every night or almost every night within the pastyear indiplon buy online cheap. Insomnia remains a disorder with high unmet medical needs, including prolongedawakenings during the night with difficulty falling back to sleep.

Neurocrine Biosciences, Inc indiplon buy online cheap. is a product-based biopharmaceutical company focusedon neurological and endocrine diseases and disorders indiplon buy online cheap. 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 buy online cheap. Neurocrine Biosciences, Inc indiplon buy online cheap. newsreleases are available through the Company's website via the Internet at www.neurocrine.com.

Copyright 2005 D-S LTD.
All Rights Reserved.