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Positive Results Reported for Indiplon Phase III SLEEP Study

SAN DIEGO, March 24 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. 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

"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

"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.

Source: Neurocrine Biosciences, Inc.

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