Neurocrine Biosciences, Inc. has 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."
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.