Neurocrine Biosciences Inc announced preliminary top line results from the Company's first indiplon modified release Phase III clinical trial, achieving statistically significant results that demonstrate patients with chronic insomnia taking indiplon 30 mg fell asleep more rapidly and stayed asleep longer. The data released today support the objective results demonstrated with indiplon utilizing polysomnographic analyses of patients in previous clinical trials.
The modified release formulation of indiplon following nightly administration of 30 mg over a two week period demonstrated a statistically significant improvement in the primary endpoint of patient reported Total Sleep Time (sTST) relative to placebo at both week 1 (placebo 332.5 min, indiplon 376.1 min, p<0.0001) and week 2 (placebo 342.3 min, indiplon 370.0 min, p<0.004). These data confirm that patients on indiplon slept significantly longer than those taking placebo and that the effect was sustained over the two week treatment period.
Indiplon modified release also demonstrated statistically significant efficacy results in sleep maintenance as compared to placebo on multiple secondary endpoints.
"The study results reinforce the potential of indiplon modified release in treating Sleep Maintenance Insomnia and in improving Sleep Quality in patients with chronic insomnia problems," said Dr. Thomas Roth, Chief, Division Head, Sleep Disorders and Research Center, Henry Ford Hospital. "The data released to date for both the immediate and modified release formulations of indiplon have demonstrated the efficacy of the compound to address the many different needs of the insomnia patient population based on several sleep parameters."