New Drug Application Submitted for Indiplon Tablets
May 27, 2005 - 5:54:00 PM
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"The indiplon NDA submissions are supported by data from one of the most comprehensive clinical trial programs conducted in insomnia which showcased the consistency with which indiplon helps patients address sleep onset and sleep maintenance problems while improving overall sleep quality."
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By Neurocrine Biosciences,
[RxPG] Neurocrine Biosciences, Inc. announced that the company has completed submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for indiplon tablets for the treatment of insomnia in both adult and elderly patients. The NDA for indiplon capsules was submitted to the FDA in April of 2005. These filings are based on clinical data supporting that both indiplon capsules and tablets show significant improvement in all sleep onset, sleep maintenance and sleep quality parameters.
"The indiplon NDA submissions are supported by data from one of the most comprehensive clinical trial programs conducted in insomnia which showcased the consistency with which indiplon helps patients address sleep onset and sleep maintenance problems while improving overall sleep quality," said Gary A. Lyons, President and CEO of Neurocrine Biosciences. "We believe that the flexibility of indiplon in treating the individual sleep needs of patients, coupled with the demonstrated long-term safety, make it an important advancement in the treatment of insomnia."
The indiplon NDA filings contain data from 72 clinical trials and include a comprehensive safety and efficacy evaluation in more than 7,500 subjects. Clinical trial results have shown that indiplon capsules and tablets help patients consistently fall asleep faster, increase the amount of time they sleep during the night, decrease number of nighttime awakenings and improve overall sleep quality over the course of short or long-term treatment without evidence of tolerance when administered nightly for up to three months or withdrawal upon discontinuation of nightly dosing -- complications often seen with extended use of older-generation sleep medications.
About Indiplon
Indiplon is a unique, non-narcotic, non-benzodiazapine agent that acts on a specific site of the GABA-A receptor. Indiplon has been shown to bind selectively to the specific subtype of GABA-A receptors within the brain believed to be responsible for promoting sleep. Indiplon was developed to address different types of sleep problems. Indiplon was licensed from DOV Pharmaceutical in 1998. Upon approval, indiplon will be copromoted in the US with Pfizer.
Insomnia is a prevalent condition in the United States. According to the National Sleep Foundation's (NSF) Sleep in America Poll 2005 approximately half of America's adults report that they experienced at least one symptom of insomnia a few nights a week or more in the past year. Sleep loss has been found to impair the ability to perform tasks involving memory, learning, and logical reasoning, yet few people understand the importance of sufficient sleep.
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Additional information about the news article
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Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, diabetes, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, and autoimmunity. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at http://www.neurocrine.com/.
In addition to historical facts, this press release may contain forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine's business and finances in general including, but not limited to, risk and uncertainties associated with the Company's indiplon program and planned regulatory activities. Specifically, the risks and uncertainties the Company faces with respect to its indiplon program include, but are not limited to; risk that the reformatted indiplon capsule and tablet NDAs will not be acceptable to the FDA; the risk that regulatory authorities may reject our regulatory submissions or find them incomplete or insufficient; risk that additional clinical studies may be required to support submissions for regulatory approval; risk that the indiplon labeling granted by regulatory authorities may limit the commercial success of indiplon; risk relating to the Company's dependence on contract manufacturers for clinical drug supply and compliance with regulatory requirements for marketing approval; risks associated with the Company's dependence on corporate collaborators for commercial manufacturing and marketing and sales activities; uncertainties relating to patent protection and intellectual property rights of third parties; risks and uncertainties relating to competitive products and technological changes that may limit demand for the Company's products; risk that the Company will be unable to raise additional funding required to complete development of all of its product candidates; and the other risks described in the Company's report on Form 10-K for the year ended December 31, 2004 and report on Form 10-Q for the quarter ended March 31, 2005. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
Neurocrine Biosciences, Inc.
CONTACT: Investors, Elizabeth Foster or Claudia Jones, both ofNeurocrine Biosciences, +1-858-617-7600; or Media, Liz Frank of Cohn & Wolfe,+1-212-798-9734, for Neurocrine Biosciences
Web site: http://www.neurocrine.com/
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