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Neurocrine Announces Additional Positive Clinical Trial Results In Sedative Activity of NBI-34060 for Insomnia (PR Newswire)...immune and endocrine systems for the development of therapeutic interventions for anxiety, depression, insomnia, stroke, malignant brain tumors, multiple sclerosis, obesity and diabetes....- Feb 15 7:31 AM ET


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Posted on: 02/15/2001

"Yahoo - Neurocrine Announces Additional Positive Clinical Trial Results In Sedative Activity of NBI-34060 for Insomnia"
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Press Release

SOURCE: Neurocrine Biosciences, Inc.

Neurocrine Announces Additional Positive Clinical Trial Results In Sedative Activity of NBI-34060 for Insomnia

Clinical Trial Results Demonstrate Safety and Tolerability In Young Adult and Elderly Patient Population

SAN DIEGO, Feb. 15 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - news) announced today additional positive results from its ongoing clinical program with NBI-34060 for insomnia. In a randomized, double-blind, placebo-controlled clinical study with multiple doses of NBI-34060 conducted in young adults and elderly subjects, results demonstrate that NBI-34060 works as a sedative-hypnotic with no major differences in the pharmacokinetics for maximum plasma levels or total drug exposure between young adults and elderly subjects. Also, there were no changes between these patient populations in the accumulation of NBI-34060 after four consecutive nightly doses. Safety evaluation and subjective measures of next day residual effect confirmed that the drug was well-tolerated in both groups with the expected sedation during the night, and with no hangover or residual carry over next-day effect. Existing sedative hypnotics such as Ambien(TM) demonstrate higher drug levels in elderly patients indicative of a slower drug clearance leading to the possibility of increased next day adverse effects.

"The elderly population, which represents a large portion of the insomnia market, would benefit greatly from a novel therapeutic. NBI-34060 continues to demonstrate clinical benefit in this important target market with a rapid onset of action and an improved safety profile over existing sedative hypnotics," said Gary A. Lyons, CEO and President of Neurocrine Biosciences. "These encouraging results further support Neurocrine's differentiation strategy for NBI-34060 over currently marketed therapeutics for insomnia."

The study, a randomized, double-blind, placebo-controlled, multiple-dose study compared the pharmacokinetics of NBI-34060 administered to elderly and young adult subjects and assessed the pharmacodynamics, safety and tolerability of NBI-34060 in both patient populations. A total of 25 healthy male and female subjects were randomized, including 13 subjects aged 65 to 79 years (elderly) and 12 subjects aged 18 to 45 years (young adults). For both elderly and young adult subjects, NBI-34060 was rapidly absorbed and eliminated.

In the clinical trial, pharmacodynamic parameters were assessed by a morning sleep questionnaire. These parameters included subjective assessments of latency to sleep onset (LSO), total sleep time (TST) and sleep quality. Both young adult and elderly subjects reported a more rapid sleep onset than placebo subjects and all NBI-34060 subjects reported a longer total sleep time and a shorter total time awake than placebo subjects after all nights of dosing. These findings were particularly true for Nights 1 and 4 when subjects were frequently disturbed for pharmacokinetic (PK) blood sampling. On those nights, there was a 77% and 43% improvement in the time it took for subjects to fall asleep for elderly and young adult subjects, respectively and an approximately 180% improvement for both groups in the total time that subjects reported they were asleep with respect to placebo. Additionally, in subjective analyses over all nights of dosing, the NBI-34060 subjects, both young adult and elderly, responded positively on sleep quality.

"The study provides additional support to the findings in more than 500 subjects already studied, that NBI-34060 demonstrates the qualities of an effective sedative hypnotic not only in inducing a rapid sleep onset but also in maintaining sleep, which in this study is particularly evident in elderly subjects during nights when subjects were awakened frequently for PK blood sampling," said Bruce Campbell, Ph.D, Senior Vice President of Development for Neurocrine Biosciences. "Further, this is accomplished with no next day residual effects relative to placebo and patients experienced a positive sleep quality. Additional studies are ongoing this year to define the optimal doses for pivotal Phase III studies expected to commence later this year."

Neurocrine Biosciences is a leading neuroscience company focused on the discovery and development of novel therapeutics for neuropsychiatric, neuroinflammatory and neurodegenerative diseases and disorders. The Company's neuroscience, endocrine and immunology disciplines provide a unique biological understanding of the molecular interaction between central nervous, immune and endocrine systems for the development of therapeutic interventions for anxiety, depression, insomnia, stroke, malignant brain tumors, multiple sclerosis, obesity and diabetes.

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 contains 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 NBI-34060 clinical program including, but not limited to, risk that the NBI-34060 clinical program will not successfully proceed to later stage clinical trials or that later stage clinical trials will not show that it is effective in treating humans; determinations by regulatory and governmental authorities; uncertainties relating to patent protection and intellectual property rights of third parties; impact of competitive products and technological changes; availability of capital and cost of capital; and other material risks. A more complete description of these risks can be found in the Company's Form 10K for the year ended December 31, 2000, as amended, the current form 10Q and its most recent registration statement, as filed with the Securities and Exchange Commission, each of which should be read before making any investment in Neurocrine common stock. 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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