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Biotech / Medical : Biotech success, 2002 -- Ignore unavailable to you. Want to Upgrade?

To: michael_f_murphy who wrote (78)	6/24/2002 6:26:39 AM
From: Elmer	Respond to of 117

Neurocrine Biosciences Announces Positive Phase II Efficacy and Safety Results With Indiplon-MR (Modified Release Formulation) Indiplon-MR Shows Statistically Significant Improvement in Sleep Maintenance In Elderly Patients With Primary Insomnia SAN DIEGO, June 24 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - News) today announced positive efficacy and safety results with indiplon-MR tablets in a Phase II clinical trial in 79 elderly patients with Primary (Chronic) Insomnia characterized by sleep maintenance difficulties. This study was a randomized, multi-center, double-blind, placebo-controlled, five-period crossover, dose-response study, in which four dose levels (10 mg, 20 mg, 30 mg, and 35 mg) of indiplon-MR tablets were tested in elderly patients aged 65 to 75 years to assess the efficacy and safety of indiplon-MR. In the primary endpoint of Sleep Efficiency (SE), defined as Total Sleep Time divided by Total Bed Time as measured objectively by polysomnography (PSG), Indiplon-MR at the 20 mg, 30 mg and 35 mg doses demonstrated a highly statistically significant improvement in SE (p<0.0001) relative to placebo. Total Sleep Time (TST) was also highly statistically significant (p<0.0001) relative to placebo. Key secondary sleep maintenance endpoints of Wake Time After Sleep Onset (WASO), Wake Time During Sleep (WTDS), and Number of Awakenings After Sleep Onset (NAASO) measurements of the effect on sleep maintenance were highly statistically significant at the above three doses compared with placebo. Not only were results statistically significant in sleep maintenance efficacy parameters but indiplon-MR also demonstrated highly statistically significant improvements in sleep initiation as determined by Latency to Persistent Sleep (LPS) (p<0.0001) as measured objectively by PSG relative to placebo. Overall, indiplon-MR was well tolerated with adverse event incidence for the active treatment groups comparable to that reported in the placebo group. Based on these results, Neurocrine has selected the doses that will be used in the remaining Phase III clinical trials with indiplon-MR in elderly patients scheduled to begin later this year. Patient reported Latency to Sleep Onset (LSO), Total Sleep Time (sTST), Wake Time After Sleep Onset (sWASO), and Number of Awakenings After Sleep Onset (sNAASO) also demonstrated statistically significant improvement over placebo at the 20 mg, 30 mg, and 35 mg doses (p<0.0001) versus placebo. These subjective efficacy data confirm the objective PSG findings discussed above. These combined positive findings indicate that the indiplon-MR treated patients not only fell asleep more rapidly but also stayed asleep longer and slept better. Visual Analogue Scale (VAS), Symbol Copy Test (SCT) and Adverse Events showed no next day residual effects compared to placebo. There was a modest effect on Digital Symbol Substitution Test (DSST) at the highest doses. Commenting on the clinical results, Dr. Thomas Roth, Chief, Division Head, Sleep Disorders and Research Center, Henry Ford Hospital said "These safety and efficacy results are strong and confirm what has been reported previously with indiplon. These new data show a dose dependent effect that is statistically significant in duration and quality of sleep in a population with a high prevalence of sleep maintenance problems. In addition, the elderly also suffer from chronic insomnia so safety is a critical factor in treating this population over the long term. These are the right results in the right patient population." "The efficacy results based on a number of different sleep parameters demonstrated the efficacy of indiplon-MR in maintaining sleep as well as initiating sleep. We are particularly excited in the robustness of the results using so many different measurements," said Henry Pan, M.D. Ph.D. Executive Vice President of Clinical Development and Chief Medical Officer for Neurocrine Biosciences. "We have previously selected the optimal doses for the pivotal Phase III clinical trials with indiplon-MR in the adult insomnia population with sleep maintenance problems and these new data have allowed us to select the optimal doses for the Phase III studies in the elderly with our modified release formulation. The remaining studies with indiplon-MR will begin within a few months and will complete our comprehensive clinical program for indiplon-MR and indiplon-IR which includes eight Phase III clinical trials involving over 3500 patients with Primary and Transient Insomnia in both adult and elderly patient populations. We are on track for the filing of a New Drug Application (NDA) with the FDA for both formulations at the end of 2003," added Pan. Indiplon 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 therapeutics also produce their sleep-promoting effects. However, indiplon is more potent than the currently marketed non-benzodiazepines, including Ambien® and Sonata®, and more selective for the specific subtype of receptors within the brain believed to be responsible for promoting sleep. Insomnia is a prevalent neurological disorder in the United States, with about one-half of the adult population reporting trouble sleeping a few nights per week or more, according to the National Sleep Foundation (NSF). Approximately 55% of the adult population reports that they experience insomnia every night or almost every night. Despite this widespread prevalence, insomnia remains a disorder with high unmet medical needs, including the ability to maintain sleep throughout the night without next-day residual effects.