Neurocrine Biosciences, Inc 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."
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 favour of indiplon compared to placebo.