And a second PR:
[EDIT:] Lyons' presentation to the Wells Fargo Securities Healthcare Conf' will be webcast at noon today.
Neurocrine's 'RESTFUL' Study Demonstrates Highly Positive Long-Term Efficacy Results with Indiplon Immediate Release
Sustained Effects on Sleep Initiation and Sleep Quality Over Entire Treatment Period
SAN DIEGO, March 24 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced positive results from the pivotal long term efficacy and safety Phase III "RESTFUL" trial with indiplon immediate release in patients with chronic insomnia, achieving highly statistically significant results in sleep initiation and sleep quality that were sustained over a three month period. The study involved 700 adult patients, ages 21 to 64 years, with chronic insomnia, in which patients received nightly administration of indiplon immediate release (10 mg or 20 mg) over the three-month period. Results demonstrated that with either of two dose levels of indiplon immediate release, patients achieved rapid sleep onset and slept longer with minimal sleep disturbances. Efficacy results with indiplon immediate release 10 mg and 20 mg doses demonstrated a highly statistically significant improvement in patient reported Latency to Sleep Onset (LSO) or the time it took patients to fall asleep (p<0.001 to p<0.0001) at all time points as compared to placebo, a 30% improvement over placebo and more than 27 minutes over baseline. Safety results demonstrated that the incidence of adverse events was similar to what had been observed in other long-term indiplon studies.
"We are excited to report these robust long term results from our RESTFUL study with indiplon immediate release," commented Dr. Henry Pan, Executive Vice President and Chief Medical Officer for Neurocrine Biosciences. "With this study, we have now completed all seven of our Phase III trials for registration with indiplon immediate release, demonstrating consistently positive results in different patient populations. Most recently, we have also completed a six-month safety extension of a separate Phase III out-patient study in elderly patients, confirming the long-term safety and lack of tolerance of indiplon."
Results on Secondary Endpoints
Secondary endpoints including patient reported Total Sleep Time (sTST), Wake After Sleep Onset (sWASO), Number of Awakenings After Sleep Onset (sNAASO), and Sleep Quality (SQ) also demonstrated a highly statistically significant improvement for both doses as compared to placebo. Evaluation of treatment response was also assessed by both patients and investigators. Indiplon demonstrated a highly statistically significant improvement in Patient Reported Outcome (PRO) as assessed by the Insomnia Severity Index. Investigator reported Global Rating for Severity of insomnia and Change as a result of treatment were both highly statistically significant over placebo and in favor of indiplon.
Study Design
The study was a randomized, double-blind, placebo-controlled, parallel- group, multi-center, out-patient Phase III clinical trial conducted over a three month period to assess the efficacy and safety of nightly administration of two doses of indiplon immediate release (10 mg and 20 mg) relative to placebo in 700 adult chronic insomnia patients. The study was conducted in 67 centers worldwide.
About Indiplon
Indiplon is a unique non-benzodiazapine agent that acts on a specific site of the GABA-A receptor. Indiplon has been shown to bind selectively to the specific subtype of GABA-A receptors within the brain believed to be responsible for promoting sleep. Two formulations of indiplon, immediate release and modified release, are being evaluated in clinical trials to address different types of sleep problems
About Neurocrine Biosciences
Neurocrine is conducting one of the most comprehensive clinical programs in insomnia to address the multiple needs of younger and older adult patients with insomnia such as sleep initiation, sleep maintenance, and long-term administration. Neurocrine has completed all of its Phase III safety and efficacy trials for the two formulations of indiplon to support New Drug Applications (NDAs), expected in mid-2004. The Phase III program alone will have data from approximately 5,000 patients with different types of insomnia. Indiplon was licensed from DOV Pharmaceutical in 1998.
Insomnia is a prevalent condition in the United States, with 40 percent of the adult population reporting trouble sleeping a few nights per week or more, according to the National Sleep Foundation's (NSF) Sleep in America Poll 2002. Approximately 35 percent of the adult population reports that they have experienced insomnia every night or almost every night within the past year. Insomnia remains a disorder with high unmet medical needs, including prolonged awakenings during the night with difficulty falling back to sleep.
Webcast Today at the Wells Fargo Securities Healthcare Conference
Neurocrine will present at the Wells Fargo Securities Healthcare Conference at the St. Regis Hotel in New York City, today Wednesday, March 24, 2004 at 12:00 PM Eastern Standard Time and 9:00 AM Pacific Standard Time. The presentation will be simultaneously webcast and can be accessed on the Company's website at neurocrine.com. The conference format will include a presentation and fireside chat. Gary Lyons, President and Chief Executive Officer of Neurocrine will respond to questions on indiplon and will highlight results from recently completed Phase III clinical trials.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, certain female and male disorders, anxiety, depression, diabetes, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, and autoimmunity. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at neurocrine.com
In addition to historical facts, this press release may contain forward- looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward looking statements are risks and uncertainties associated with the Company's indiplon clinical development program and planned regulatory activities. Specifically, the risks and uncertainties the Company faces with respect to its indiplon program include, but are not limited to, risk that indiplon may not successfully proceed through Phase III clinical trials or Phase III clinical trials may fail to demonstrate that indiplon is safe and effective in treating humans; risk that the Company may not complete indiplon Phase III clinical trials on the Company's projected timelines for various reasons, including the possibility that patient recruitment may be slower than expected; risk that the clinical investigators and contract research organizations upon which the Company relies to conduct its clinical programs may not be diligent, careful or timely, and may make mistakes, in the conduct of the programs; risk relating to the Company's dependence on contract manufacturers for clinical drug supply and compliance with regulatory requirements for marketing approval; risk that the Company may not successfully co-ordinate the completion and submission of planned regulatory filings on the Company's projected timelines; risk that the Company may not receive regulatory approval for indiplon or approval may be delayed; risks associated with the Company's dependence on corporate collaborators for commercial manufacturing and marketing and sales activities; uncertainties relating to patent protection and intellectual property rights of third parties; risks and uncertainties relating to competitive products and technological changes that may limit demand for the Company's products; risk that the Company will be unable to raise additional funding required to complete development of all of its product candidates; and the other risks described in the Company's Form 10-K for the year ended December 31, 2003. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
SOURCE Neurocrine Biosciences, Inc.
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