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

To: keokalani'nui who wrote (1231)	5/4/2004 4:00:57 PM
From: keokalani'nui	Respond to of 1834

Neurocrine Biosciences Announces Study Showing Indiplon Immediate Release Safe for Middle of the Night Dosing Without Next Day Residual Effects Tuesday May 4, 3:00 pm ET Data Presented at the American Psychiatric Association (APA) Meeting NEW YORK, May 4 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - News) announced results from a study in healthy volunteers presented today that shows that indiplon immediate release when taken in the middle of the night (MOTN) is safe and well tolerated without evidence of next day residual effects. These results were presented at the 157th annual meeting of the American Psychiatric Association (APA) in New York City. ADVERTISEMENT "This is promising data for patients who have trouble staying asleep and wake up frequently in the middle of the night. They are often concerned that taking a sleep medication will leave them feeling groggy the next day," said Dr. Marty Scharf, Director, Tri-State Sleep Disorders Center and Clinical Professor of Psychiatry at the Wright State University Department of Psychiatry. "This study is exciting as it suggests this patient population can safely take indiplon immediate release without impacting their next day functioning." No Evidence of Next Day Residual Effects with Indiplon Immediate Release Results were presented from the Company's indiplon immediate release Phase I five-way crossover, randomized, double-blind, placebo and active drug controlled, single center clinical trial designed to assess safety and tolerability of indiplon, zolpidem 10 mg and zopiclone 7.5 mg administered in the middle of the night (MOTN) compared with placebo. The data showed that indiplon immediate release 10 mg or 20 mg doses administered MOTN was well tolerated and subjects did not experience next morning residual effects as compared to placebo using the three validated measurements of Digital Symbol Substitution Test (DSST), Symbol Copy Test (SCT), and Visual Analog Scale (VAS) for sleepiness. Results demonstrated that there were no significant changes from pre-dosing baseline in the VAS sleepiness ratings for either indiplon immediate release 10 mg or 20 mg at four hours or at six hours post dosing as compared to placebo. In contrast, zopiclone 7.5 mg showed a significant increase in sleepiness on VAS compared to placebo at both four hours and six hours post dosing. Similarly, zolpidem 10 mg showed a significant increase in sleepiness compared to placebo at four hours post dosing. The MOTN dosing did not affect DSST or SCT at either time point for any drug administered. Safety results demonstrated that adverse events were comparable to placebo for both doses of indiplon immediate release and zolpidem. However, treatment-related adverse events were notably higher with zopiclone. The study was conducted on an in-patient basis with 35 healthy subjects, aged 18 to 45 years. Subjects were awakened to an alert state 4 hours after they had fallen asleep at which time indiplon, zolpidem, zopiclone or placebo was administered. After falling back to sleep, subjects were awakened four hours later and residual effects were tested upon awakening and again two hours later using the three validated measurements of sleepiness. "These results demonstrate that indiplon immediate release when administered to adult subjects after middle of the night is safe and well tolerated with no evidence of next morning residual effects. These findings are also consistent with a previously reported Phase I MOTN study conducted in the elderly population," said Dr. Henry Pan, Executive Vice President and Chief Medical Officer for Neurocrine Biosciences. __________ (Zolpidem is Ambien)