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Strategies & Market Trends : Sharck Soup -- Ignore unavailable to you. Want to Upgrade?

To: Sharck who wrote (31129)	7/17/2001 7:36:39 AM
From: canmar	Respond to of 37746

Great news for all you 24-hr. a day workaholics that never seem to sleep: Efficacy Has Been Achieved in Both Primary and Secondary Endpoints for Sleep Initiation and Sleep Maintenance; Pivotal Phase III Studies to Begin Q4, 2001 SAN DIEGO, July 17 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced dose related positive efficacy results with all four doses of NBI-34060 in a Phase II study in the target population of Chronic Insomnia. This study was a randomized, multi-center, double-blind, placebo and active-drug controlled, six-way crossover dose response study in 59 enrolled patients with chronic primary insomnia, designed to evaluate efficacy and to select doses to proceed into pivotal Phase III studies. The primary efficacy endpoint of this study was Latency to Persistent Sleep (LPS) or time to sleep onset as measured objectively by polysomnography (PSG). In this study NBI-34060 demonstrated a statistically significant effect on LPS relative to placebo at all dose levels (p< 0.016) with up to 46% improvement in the primary endpoint of time to sleep onset. In addition, up to 80% of the treated patients responded by going to sleep within 30 minutes. Secondary efficacy endpoints as measured objectively by PSG also demonstrated statistically significant and dose related improvements on Total Sleep Time (TST), Sleep Efficiency (SE) and a reduction in Wake After Sleep Onset (WASO) at all dose levels (p< 0.018) indicating that the NBI-34060 treated patients not only fell asleep more rapidly but also stayed asleep longer. There were no clinically relevant effects of next day residual effects observed with NBI-34060 at any dose level relative to placebo using the accepted standardized sedation tests of Digital Symbol Substitution Test (DSST), Symbol Copy Test (SCT) and the Visual Analogue Scale (VAS) of sleepiness. Overall, NBI-34060 was found to be safe and well tolerated after approximately 470 administered doses. The safety profile in these patients with Chronic Insomnia is consistent with that seen in previous studies conducted with NBI-34060 and confirm that it is well tolerated with no clinically relevant effects on next day residual sedation Based on these positive safety and robust efficacy results in the target population of chronic insomnia, Neurocrine will select final doses for pivotal Phase III clinical studies with NBI-34060, which are expected to begin by the fourth quarter of 2001. "These data support the safety and effectiveness of NBI-34060. In addition to inducing sleep, NBI-34060 shows an ability to maintain sleep and even decrease wakefulness during the night at multiple doses. This bodes well for future studies of NBI-34060 for the long term management of insomnia," said Dr. Thomas Roth, Chief, Division Head, Sleep Disorders and Research Center, Henry Ford Hospital. The clinical development of NBI-34060 is proceeding to plan with multiple safety studies successfully completed. Phase II efficacy clinical studies required for registration are also progressing well with the enrollment of more than 900 subjects to date. Other than the expected effects associated with sedation, side effects are few and the drug is well tolerated when taken either at the beginning or in the middle of the night with no next day residual effects. The study was designed with an active control to validate the efficacy results. Zolpidem 10mg (Ambien(R)) was used as the active control in the six-way crossover randomized Phase II clinical trial. The study was not designed to compare NBI-34060 to Ambien(R). While both drugs showed statistically significant results as compared to placebo, no comparative results can be derived from this study design. "These positive Phase II results support the continued and accelerated development of NBI-34060 into pivotal Phase III clinical trials. It has confirmed that NBI-34060 is well tolerated and is a robust sedative hypnotic agent, effective on all sleep measures at all doses investigated. We are now in a position to select the optimal doses going into Phase III," said Bruce Campbell, Ph.D., Senior Vice President of Development for Neurocrine Biosciences. "Neurocrine is developing NBI-34060 to serve as the complete sleep solution for all insomnia patients: for sleep initiation, night awakenings and total sleep maintenance. These encouraging Phase II results in the chronic insomnia population combined with previous findings in patients with transient insomnia further support NBI-34060 as a viable competitor in the $2 billion sedative hypnotic market," said Gary A. Lyons, President and CEO of Neurocrine Biosciences. NBI-34060 is a non-benzodiazepine that acts on a specific site of the GABA-A receptor. It is through this mechanism that the currently marketed non-benzodiazepine therapeutic also produce their sleep-promoting effects. Insomnia is a term used to describe conditions related to the perception of inadequate or non-restful sleep. It encompasses a heterogeneous set of complaints reflecting difficulties initiating and/or maintaining sleep. Insomnia is one of the most prevalent neurological disorders in the United States, with up to 58% of the adult population reporting one or more symptoms of insomnia each year, according to the National Sleep Foundation (NSF).