Indiplon Shows Significant Benefits in Chronic Insomnia
May 27, 2005 - 5:36:00 PM
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"This study demonstrates the ability of indiplon to help patients not only fall asleep but maintain sleep throughout the night and shows the effectiveness of indiplon capsules in treating the varying sleep needs of patients with insomnia."
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By Neurocrine Biosciences,
[RxPG] Neurocrine Biosciences, Inc. announced that data presented at the 2005 American Psychiatric Association (APA) Annual Meeting showed that nightly administration of indiplon capsules resulted in significant and sustained improvement in sleep onset and sleep maintenance in patients with chronic insomnia over the entire treatment period.
Data also showed there was no evidence of tolerance over the three months or withdrawal upon discontinuation of treatment -- complications often seen with extended use of older-generation sleep medications.
"This study demonstrates the ability of indiplon to help patients not only fall asleep but maintain sleep throughout the night and shows the effectiveness of indiplon capsules in treating the varying sleep needs of patients with insomnia," said Dr. Martin Scharf of the Tri-State Sleep Disorders Center. "Importantly, this study shows that indiplon can be given over long periods of time without inducing tolerance, a key concern to physicians treating patients with chronic insomnia. Furthermore, indiplon was shown to be safe and effective without next-day residual effects for long-term treatment of chronic insomnia."
The study, which was conducted in 67 centers worldwide, was a randomized, double blind, placebo-controlled trial evaluating the safety, efficacy, and tolerability of indiplon capsules in 702 patients with moderate to severe chronic insomnia. Patients were randomized to three months of treatment with either indiplon 10 mg or 20 mg capsules, or placebo.
Patients Consistently Fell Asleep Faster With Indiplon
The primary endpoint for the clinical study was Latency to Sleep Onset (LSO) or the time it takes patients to fall asleep, as reported by patients. Data showed that indiplon capsules resulted in significant and sustained improvements in LSO (p less than 0.0001 to p less than 0.0004) and provided patients with 50% improvement in LSO from baseline. The mean improvement from baseline LSO for the indiplon treatment groups was as high as 27.2 minutes for the 10mg group and 27.6 minutes for the 20mg group compared to a maximum of 18 minutes for the placebo group over the three-month dosing period.
Patients Gained an Hour of Sleep and Slept Through the Night
The study also assessed several subjective secondary endpoints including Total Sleep Time (sTST), Wake After Sleep Onset (sWASO) and Number of Awakenings after Sleep Onset (sNAASO) which are used to assess sleep maintenance effects. Results showed that indiplon capsules resulted in significant improvements in sTST (all p<0<0<0
Publication:
The data was presented at the 2005 American Psychiatric Association (APA) Annual Meeting.
On the web:
www.neurocrine.com 
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Additional information about the news article
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Additional Indiplon Data Presented at APA
Data from three additional studies evaluating the safety and efficacy of indiplon are also being presented at the APA annual meeting on Wednesday, May 25, 2005 at 12:00 PM EDT.
Efficacy and Tolerability of Indiplon IR (capsules) in Elderly Patient with Chronic Insomnia
Efficacy and Tolerability of Indiplon MR (tablets) in Elderly Patients with Chronic Insomnia
Efficacy and Safety of Indiplon IR (capsules) in Adults with Chronic Insomnia Characterized by Prolonged Nighttime Awakenings with Difficulty Returning to Sleep
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, 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 http://www.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 Neurocrine's business and finances in general including, but not limited to, risk and uncertainties associated with the Company's indiplon 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 the company may not be able to submit indiplon regulatory filings with company's protected timeline; the risk that regulatory authorities may reject our regulatory submissions or find them incomplete or insufficient; risk that additional clinical studies may be required to support submissions for regulatory approval; risk that the indiplon labeling granted by regulatory authorities may limit the commercial success of indiplon; risk relating to the Company's dependence on contract manufacturers for clinical drug supply and compliance with regulatory requirements for marketing approval; 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 report on Form 10-K for the year ended December 31, 2004 and most recent report on Form 10Q. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
CONTACT: Investors, Elizabeth Foster, or Claudia Jones, both of NeurocrineBiosciences, +1-858-658-7600; or Media, Lisa Talbot of Cohn & Wolfe,+1-212-798-9836, or mobile, +1-347-210-8708, for Neurocrine Biosciences,Inc.
Web site: http://www.neurocrine.com/
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