SAN DIEGO, Calif., Nov. 22 /PRNewswire-FirstCall/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) announced that it has submitted a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA) for
regulatory approval of indiplon modified release tablets for the treatment of
insomnia. The application contains safety and efficacy results from 8 Phase
III clinical trials with indiplon modified release conducted in adult and
elderly patients with transient and chronic insomnia. The NDA for indiplon
immediate release capsules was submitted to the FDA on October 18 of this
year.
This NDA submission contains manufacturing and clinical information
specific to the modified release formulation. The first NDA submitted in
October for indiplon immediate release included non-clinical, clinical, and
manufacturing information that was common to both applications. The NDAs have
been submitted in electronic common technical document format (e-CTD) and
include data from a comprehensive safety and efficacy evaluation in over 7500
subjects.
"Patients with insomnia experience a wide range of symptoms such as
trouble falling asleep, trouble staying asleep, and waking up frequently
during the night. However, no two patients are alike as symptoms vary from
patient to patient. The two formulations of indiplon will be an important
advance in allowing physicians to tailor treatment to help improve patients'
individual insomnia symptoms and, as a result, sleep quality. Clinical trials
consistently showed that patients fell sleep quickly and stayed asleep longer
when modified release tablets were taken at bedtime," said Dr. Thomas Roth,
Director Sleep Disorders Center, Henry Ford Hospital.
"The submission of the two NDAs for indiplon represents a great
achievement for Neurocrine that will turn the focus of the Company towards
commercialization. We believe that indiplon will set a new standard in the
way physicians treat and manage insomnia. We are now moving forward with our
partner, Pfizer, in preparing for the commercialization of indiplon, while
building and training the Neurocrine sales force to co-detail Zoloft(R) with
Pfizer to psychiatrists," said Gary A. Lyons, President and CEO of Neurocrine
Biosciences.
About Indiplon
Indiplon is a unique 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. Two formulations of indiplon, immediate
release capsules and modified release tablets, have been evaluated in clinical
trials to address different types of sleep problems. Indiplon was licensed
from DOV Pharmaceutical in 1998.
Insomnia is a prevalent condition in the United States, with approximately
40 percent of the adult population reporting trouble sleeping a few nights per
week or more, according to the National Sleep Foundation's (NSF) Sleep in
America Poll 2002. Approximately 35 percent of the adult population reports
that they have experienced insomnia every night or almost every night within
the past year. Insomnia remains a disorder with high unmet medical needs,
including problems of frequent night time awakenings and difficulty falling
back to sleep, sometimes referred to as sleep fragmentation.
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, 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,
the risk that regulatory authorities may reject our regulatory filings or find
them incomplete or insufficient; risk that additional clinical studies may be
required to support filings for regulatory approval; risk relating to the
Company's dependence on contract manufacturers for clinical drug supply and
compliance with regulatory requirements for marketing approval; risk that the
Company may not receive regulatory approval for indiplon or approval may be
delayed; risks associated with the Company's dependence on corporate
collaborators for commercial manufacturing and marketing and sales activities;
risk that the indiplon labeling granted by regulatory authorities may limit
the commercial success of indiplon; 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, 2003 and most recent report on
Form 10-Q filed for the third quarter ended, September 30, 2004. Neurocrine
undertakes no obligation to update the statements contained in this press
release after the date hereof.
SOURCE Neurocrine Biosciences, Inc.
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Related links:
http://www.neurocrine.com
CONTACT:
Investor Contacts, Elizabeth Foster,
+1-858-617-7757, or Claudia Jones, +1-858-617-7759, both of
Neurocrine Biosciences; or Media Contact, Liz Frank of Cohn &
Wolfe, +1-212-798-9734, for Neurocrine Biosciences, Inc.
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