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

To: scaram(o)uche who wrote (1209)	3/1/2004 9:17:46 AM
From: tuck	Read Replies (1) \| Respond to of 1834

NBIX trying to steal a bit of SEPR thunder this morning: >>SAN DIEGO, March 1 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - News) today announced positive results from its Phase III trial with the modified release formulation of indiplon, achieving highly statistically significant results in adults with transient insomnia. The study was a randomized, double-blind, placebo-controlled, parallel-group, multi-center sleep laboratory Phase III clinical trial. The primary objective of the study was to assess the efficacy of two dose levels of indiplon modified release (20 mg and 30 mg) relative to placebo on sleep initiation in 325 healthy adult subjects. The primary endpoint for the study was Latency to Persistent Sleep (LPS), or time to sleep onset, as measured objectively by polysomnography (PSG). Indiplon modified release demonstrated a statistically significant reduction in LPS at both dose levels (p<0.0001) as compared to placebo. Improvements over placebo were approximately 50% for both dose groups. Patient reported Latency to Sleep Onset (LSO), or the amount of time it took subjects to fall asleep, was also significantly reduced (p<0.0001) for both doses, with a greater than 50% improvement relative to placebo. Safety results demonstrated that indiplon modified release was well tolerated and the incidence of adverse events for the indiplon treatment groups was similar to those studies we have conducted previously in the same population. In addition, there were no serious adverse events in the study. "We are excited about the clinical results for our first Phase III clinical trial with indiplon modified release in transient insomnia. These results demonstrate the versatility of the modified release formulation and will enhance the data set for the modified release formulation with this new data on sleep initiation," said Dr. Henry Pan, Executive Vice President and Chief Medical Officer for Neurocrine Biosciences. Study Design This Phase III study was conducted in 11 centers in North America using a sleep laboratory model of the first night effect in a new environment combined with a phase advance (advancing subjects' bedtime 2 hours earlier than their normal bedtime) for the purpose of inducing transient insomnia in normal healthy adult volunteers who otherwise have a normal sleep pattern.<< snip Cheers, Tuck