Restful sleep from Neurocrine

San Diego-based Neurocrine Biosciences has announced positive results from the pivotal long term efficacy and safety Phase III 'RESTFUL trial with in-diplon immediate release in patients with chronic insomnia, achieving highly statistically significant results in sleep initiation and sleep quality that were sustained over a three month period.

The study involved 700 adult patients, ages 21 to 64 years, with chronic insomnia, in which patients received nightly administration of indiplon immediate release (10 mg or 20 mg) over the three-month period. Results demonstrated that with either of two dose levels of indiplon immediate release, patients achieved rapid sleep onset and slept longer with minimal sleep disturbances. Efficacy results with indiplon immediate release 10 mg and 20 mg doses demonstrated a highly statistically significant improvement in patient reported Latency to Sleep Onset (LSO) or the time it took patients to fall asleep (p<0.001 to p<0.0001) at all time points as compared with placebo, a 30% improvement over placebo and more than 27 minutes over baseline. Safety results demonstrated that the incidence of adverse events was similar to what had been observed in other long-term indiplon studies.

'We are excited to report these robust long term results from our RESTFUL study with indiplon immediate release,' commented Dr Henry Pan, executive vice president and chief medical officer for Neurocrine Biosciences. 'With this study, we have now completed all seven of our Phase III trials for registration with indiplon immediate release, demonstrating consistently positive results in different patient populations. Most recently, we have also completed a six-month safety extension of a separate Phase III out-patient study in elderly patients, confirming the long-term safety and lack of tolerance of indiplon.'