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Positive Results Reported for Indiplon Phase III Trial In Elderly Patients With Chronic Insomnia

SAN DIEGO, Feb. 18 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. today 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

"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, Executive Vice President and 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.

Study Design

The study was a Phase III randomized, placebo-controlled, double-blind, parallel-group, outpatient, multi-center study to assess the efficacy and safety of two dose levels of indiplon immediate release (5 mg and 10 mg) in 360 elderly patients with chronic insomnia. The trial was conducted in approximately 50 centers in North America. Patients were evaluated over a two week treatment period, and were eligible to continue in a six month open-label extension of this trial.

About Indiplon

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. There are two formulations of indiplon, immediate release and modified release. Both formulations are being studied in clinical trials to address different types of sleep problems

Insomnia is a prevalent condition in the United States, with nearly one-half 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.

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