New PR from NBIX: Neurocrine's 'SLEEP' Study Demonstrates Highly Positive Long-Term Efficacy Results With Indiplon Modified Release
A frontal assault on ESTORRA's claims to this part of the market, and SEPR down a bit today. Also, 90 minutes is a lot.
Patients Gained Up to 90 Minutes of Total Sleep Time - Sustained Throughout Study
SAN DIEGO, March 24 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced a second long term Phase III trial with highly positive efficacy results from its three month pivotal study, referred to as "SLEEP," the Study of Long-term Efficacy and Safety of indiplon modified release in Primary (Chronic) Insomnia patients. Preliminary results demonstrated that patients who took indiplon modified release either 20 mg or 30 mg nightly achieved rapid sleep onset, maintained high quality sleep throughout the night, and showed improvement in quality of life endpoints. Indiplon treatment demonstrated a highly statistically significant improvement in sleep for all primary and secondary endpoints compared to placebo for both doses and all time points (p<0.0001). Patients on both doses of indiplon reported an increase of up to 75 minutes compared to placebo in Total Sleep Time (sTST), the primary endpoint for the study, and up to 90 minutes improvement over baseline. This positive effect was sustained over the three- month period. Safety results were similar to what had been observed in other indiplon modified release studies.
"We are very pleased to report these impressive results from our SLEEP study, the first long term Phase III clinical trial with indiplon modified release, demonstrating that patients were able to resolve their many symptoms of insomnia over a prolonged treatment period. The highly beneficial effects were sustained over the three-month period of the study," said Dr. Henry Pan, Executive Vice President and Chief Medical Officer for Neurocrine Biosciences. "With the long term SLEEP and RESTFUL trials, we now have in our Phase III program a database of over 5000 patients which confirms that indiplon can significantly improve sleep in patients with transient and chronic insomnia. Indiplon has consistently demonstrated it is effective in inducing and maintaining sleep with improved sleep quality."
Results on Secondary Endpoints
Secondary sleep maintenance endpoints including patient reported Total Wake Time (sTWT), Wake After Sleep Onset (sWASO), Number of Awakenings After Sleep Onset (sNAASO) also demonstrated a highly statistically significant improvement for both doses as compared to placebo over the three-month dosing period. For sleep initiation endpoints, patient reported Latency to Sleep Onset (LSO) was also highly statistically significant for both doses compared to placebo (p<0.0001) and Sleep Quality was improved in the indiplon groups compared to placebo (p<0.0001). Evaluation of treatment response was also assessed by both patients and investigators. Indiplon demonstrated a highly statistically significant improvement in Patient Reported Outcomes including measures of Quality of Life such as Vitality, and Insomnia Severity Index when compared to placebo. Investigator reported Global Rating for Severity of insomnia and Change as a result of treatment were both highly statistically significant in favor of indiplon compared to placebo.
"The results of this study demonstrated robust long term efficacy data. There was evidence of sustained effects on all the standard measures of sleep initiation and sleep maintenance. This effect was more durable and of a greater magnitude than what we have seen in the literature to date. This trial also demonstrated consistency in patients' feelings of improved sleep quality and time asleep based on daily recordings in patient's diaries and as measured at each monthly interval of continued treatment," said Dr. Marty Scharf, Director, Tri-State Sleep Disorders Center and Clinical Professor of Psychiatry at the Wright State University Department of Psychiatry.
"There is a pressing need for newer sleep medications for long-term use, and the indiplon results released today support a greater confidence in the role sleep medications can now play in treating people with chronic insomnia. Patients in this trial reported sustained and significant quality of life changes as a result of their increased sleep time, including better next day functioning and improved work productivity and benefits," said Dr. John Winkelman, Medical Director, Sleep Health Center, Brigham and Women's Hospital. "With this new positive long-term data, physicians and also patients should feel more comfortable that drugs like indiplon can be used in the long- term management of insomnia."
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 dosing period to assess the efficacy and safety of nightly administration of two doses of indiplon modified release (20 mg and 30 mg) relative to placebo in 740 adult chronic patients ages 21 to 64 years with sleep maintenance difficulties. The primary and secondary endpoints for the three-month blinded study included all standard measures of sleep maintenance and sleep quality as well as sleep initiation. In addition, patients were given questionnaires to comment on their overall well being and quality of life issues. Data for the primary and secondary endpoints were collected in patient diaries on a daily basis. The study was conducted in 70 sleep 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 both formulation 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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