Neurocrine Biosciences, Inc. announced positive results from its Phase III clinical trial with two doses (5 mg and 10 mg) of the immediate release formulation of indiplon, achieving statistically significant results in elderly patients with chronic insomnia.
Results of the primary endpoint for this study, Latency to Sleep Onset (LSO) or the amount of time it took patients to fall asleep, as measured by patient self reported outcomes was statistically significant for both doses (p<0.02 at 5 mg and p<0.005 at 10 mg) as compared to placebo. For LSO, the time to sleep was shortened by more than 27 minutes for both indiplon doses, more than a 40 per cent reduction from baseline.
Secondary endpoints, including patient self reported Total Sleep Time (sTST), Wake After Sleep Onset (sWASO), and Number of Awakenings After Sleep Onset (sNAASO) were also statistically significant as compared to placebo. Sleep quality was significantly improved (p<0.005) at both dose levels as compared to placebo. Results confirmed that elderly patients with chronic insomnia who took indiplon fell asleep more rapidly and stayed asleep longer with fewer awakenings and reported improved sleep quality. Additionally, indiplon immediate release was well tolerated and there were no treatment related serious adverse events reported in the study.
"We are pleased with the first Phase III clinical trial results demonstrating that indiplon immediate release formulation is safe and effective in treating elderly patients who experience many different symptoms of chronic insomnia," said Henry Pan, chief medical officer for Neurocrine Biosciences. "We are confident that these data will demonstrate the potential of indiplon to meet the needs of many populations such as the elderly."
"Indiplon has now consistently demonstrated that it helps patients fall asleep faster, stay asleep longer and improves their quality of sleep with no important safety issues. Indiplon (immediate release) formulation could provide a treatment option targeting chronic insomnia, a prevalent and growing problem among elderly patients," said Dr Thomas Roth, chief, Division Head, Sleep Disorders and Research Center, Henry Ford Hospital.