Efficacy results with indiplon MR tablets demonstrated a highly statistically significant and clinically relevant improvement on the primary endpoint of patient reported total sleep time, as compared to placebo over the four weeks of treatment.
Patients receiving indiplon gained approximately one hour of sleep over baseline. Safety results were consistent with those previously reported in other phase III indiplon studies.
The study was a randomized, double-blind, placebo-controlled, out-patient phase III clinical trial conducted in 248 adult patients with sleep maintenance difficulties across 50 sleep centers in the US.
“All sixteen phase III trials with indiplon have demonstrated positive results, making this one of the most solid clinical evaluations of any new drug candidate,” said Dr Henry Pan, executive vice president and chief medical officer for Neurocrine Biosciences.
“As we had seen with the same measurements in our previous elderly study, the 15mg dose showed significant improvement in sleep maintenance at every primary and secondary endpoint, as well as in next day functioning and alertness in this adult patient population. More importantly, this study also demonstrated favorable patient and investigator reported outcomes as well as in quality of life improvement,” he continued.
The results from this trial will support a new drug application (NDA) for indiplon MR that Neurocrine expects to submit in Q2 2005. The company believes indiplon MR and IR will provide treatment options for all sleep difficulties including sleep initiation and maintenance, and for long-term chronic usage.