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indiplon package insert |
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indiplon package insert Neurocrine Submits New Drug Application (NDA) for Indiplon Immediate Release Capsulesfor the Treatment of Insomnia The NDA has been submitted in electronic common technical document format (e-CTD) indiplon package insert. 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 package insert. 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 package insert. Indiplon capsules and tablets have consistentlydemonstrated robust efficacy and safety in repeated clinical evaluations, measuringmultiple parameters of sleep difficulties indiplon package insert. These results confirm that indiplonwill offer physicians a significant improvement in the diagnosis and treatmentof patients' individual sleep needs," said Dr indiplon package insert. 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 package insert. Indiplon is an important advancement inthe treatment of insomnia as it was specifically designed and developed to addressthe individual sleep needs of patients indiplon package insert. Indiplon capsules have consistentlydemonstrated that patients fall asleep faster, have improved sleep quality andsleep duration indiplon package insert. 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 package insert. We are pleased to have Pfizer, the leading global pharmaceuticalcompany, as our partner in the development and commercialization of indiplon,"said Gary A indiplon package insert. Lyons, President and CEO of Neurocrine Biosciences. About Indiplon 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 package insert. Approximately 35 percent of the adult population reports that theyhave experienced insomnia every night or almost every night within the pastyear indiplon package insert. Insomnia remains a disorder with high unmet medical needs, including prolongedawakenings during the night with difficulty falling back to sleep. Neurocrine Biosciences, Inc indiplon package insert. is a product-based biopharmaceutical company focusedon neurological and endocrine diseases and disorders indiplon package insert. 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 package insert. Neurocrine Biosciences, Inc indiplon package insert. newsreleases are available through the Company's website via the Internet at www.neurocrine.com. |
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