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Improved Total Sleep Time Demonstrated in Phase 3 Trial of Indiplon
The study was a randomized, double-blind, placebo-controlled, parallel-group, multi-center, out-patient Phase III clinical trial conducted in 248 adult patients with sleep maintenance difficulties. The study was conducted at 50 sleep centers in the U.S. Patients received nightly administration of 15 mg of indiplon MR tablets or placebo over a four-week period. The endpoints in this trial were the same as those studied in our elderly trial utilizing the 15 mg dose.
"These results once again confirmed the robustness, consistency, clinical relevance and safety profile of the data for indiplon. 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 15-mg 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. Neurocrine expects to submit an NDA for indiplon MR in the 2nd Quarter of 2005 that will include the results of this trial. We believe the registration of indiplon MR and IR will provide a broad spectrum of treatment for all sleep difficulties including sleep initiation, and sleep maintenance, and long term chronic usage," added Pan.
Indiplon is a unique non-benzodiazapine agent that acts on a specific site of the GABA-A receptor. Indiplon has been shown to bind selectively to the specific subtype of GABA-A receptors within the brain believed to be responsible for promoting sleep. Two formulations of indiplon, IR capsules and MR tablets, are being evaluated in clinical trials to address different types of sleep problems. Indiplon was licensed from DOV Pharmaceutical in 1998.
Insomnia is a prevalent condition in the United States, with approximately 40 percent of the adult population reporting trouble sleeping a few nights per week or more, according to the National Sleep Foundation's (NSF) Sleep in America Poll 2002. Approximately 35 percent of the adult population reports that they have experienced insomnia every night or almost every night within the past year. Insomnia remains a disorder with high unmet medical needs, including prolonged awakenings during the night with difficulty falling back to sleep.
Source: Neurocrine Biosciences, Inc.