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Biotech / Medical : Neurocrine Biosciences (NBIX) -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (1179)	11/10/2003 7:01:36 PM
From: Miljenko Zuanic	Respond to of 1834

SAN DIEGO, Nov. 10 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - News) today announced results from the Company's indiplon immediate release Phase I clinical trial. The data showed that elderly subjects given indiplon 5 mg or 10 mg doses with middle of the night (MOTN) administration did not experience next morning residual effects as compared to placebo using standard measurements of psychomotor function and alertness. In the same study, patients given zopiclone 3.75 mg, the approved starting dose in Europe for the treatment of elderly patients with insomnia, experienced significant impairment the next morning as compared with placebo. The study was a Phase I four-way crossover randomized, double-blind, placebo and active drug controlled, single center clinical trial designed to assess safety and tolerability of indiplon and zopiclone compared with placebo. The study was conducted in Europe on an in-patient basis with 36 healthy elderly subjects, aged 65 to 73 years. Subjects were awakened to an alert state four hours after they had fallen asleep at which time indiplon, zopiclone or placebo was administered. After falling back to sleep, subjects were awakened four hours post dose and psychomotor tests were conducted over the next four hours. Next day residual effects were assessed immediately after awakening at four hours, and also at six and eight hours post dosing the next morning using the three validated measurements of Digital Symbol Substitution Test (DSST), Symbol Copy Test (SCT), and Visual Analog Scale (VAS) of sleepiness. Pharmacodynamic and safety results demonstrated that the 5 mg and 10 mg doses of the immediate release formulation of indiplon were well tolerated and there were no statistically significant differences in next day residual sedation as measured by DSST, SCT, and VAS as compared with placebo (p = not significant at all time points for both doses and with all three measurements). However, zopiclone 3.75 mg demonstrated statistically significant impairment the next morning as compared with placebo at 4 hours (p=0.001) and 8 hours (p=0.014) post dose using DSST, one of the three validated measurements used in this study. A trend toward impairment was also demonstrated for zopiclone at 4 hours (p=0.092) and 6 hours (p=0.086) post dose using SCT, another validated measure. There were no serious adverse events in the study. The incidence of AEs for the indiplon treatment groups was comparable to placebo. "These results demonstrate that indiplon immediate release is safe and well tolerated when administered to elderly subjects after middle of the night administration. There was no evidence of next morning residual effects. These findings are consistent with an earlier study we did in the younger adult population," said Dr. Henry Pan, Executive Vice President and Chief Medical Officer for Neurocrine Biosciences Neurocrine is also conducting a Phase II randomized, placebo controlled, double blind, parallel group, multi-center study to assess the efficacy and safety of MOTN administration of indiplon immediate release 10 mg and 20 mg doses as compared to placebo in 264 adult patients with chronic insomnia with frequent and prolonged MOTN awakenings. This study is being conducted on an outpatient basis over a four-week treatment period. The primary endpoint for this study is patient reported Latency to Sleep Onset (LSO) post dosing in the middle of the night at weeks two and four. "This study represents a new area for the treatment of insomnia. Indiplon is the first insomnia treatment to evaluate efficacy, safety and next morning residual effects associated with treating extended awakenings in the middle of the night. We are planning to report the results of our Phase II clinical trial with indiplon immediate release after middle of the night administration in 264 patients by year-end 2003," added Pan.