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Study: Indiplon Helps Insomniacs Fall Asleep Quicker and Stay Asleep Longer

SAN DIEGO, Sept. 24 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. today 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

Indiplon modified release also demonstrated statistically significant efficacy results in sleep maintenance as compared to placebo on multiple secondary endpoints. These endpoints included patient reported Wake After Sleep Onset (sWASO, p

In addition a key secondary efficacy endpoint of patient reported Latency to Sleep Onset (LSO), or the amount of time it took subjects to fall asleep, also demonstrated statistically significant improvements in the indiplon treated group as compared to the placebo group (p

Evaluation of treatment response was also assessed by both patients and investigators. Indiplon patients reported a statistically significant improvement in the quality of their sleep compared to the placebo group (p

"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."

Safety results demonstrated that the 30 mg dose of the modified release formulation of indiplon was well tolerated. There were no serious adverse events in the study. The adverse events reported in the study were in line with the pharmacological effect of indiplon and were consistent with previous clinical trial results.

"These results demonstrate that indiplon modified release is highly effective in patients with sleep maintenance insomnia showing positive outcomes in all primary and secondary endpoints. In addition to this being the first Phase III outpatient study, we are also reporting for the first time investigator and patient reported global ratings of the effectiveness of indiplon in this patient population," said Henry Pan, Executive Vice President and Chief Medical Officer for Neurocrine Biosciences.

Study Design and Overall Indiplon Program

The study was a randomized, double-blind, placebo-controlled, parallel group, multicenter Phase III clinical trial designed to assess the safety and efficacy of the modified release formulation of indiplon tablets (30 mg). The study involved 211 adult patients at 32 centers in the U.S. with Chronic Primary Insomnia. Patients received treatment on an outpatient basis over a two-week treatment period.

Neurocrine is conducting one of the most comprehensive clinical programs in insomnia to address the multiple needs of younger and older adult patients with insomnia such as sleep initiation, sleep maintenance, and long-term administration. Neurocrine has initiated and is completing all of its Phase III safety and efficacy trials to support a New Drug Application (NDA) expected in the first half of 2004 for indiplon for multiple insomnia indications. The Phase III program alone will have data from over 4,000 patients with different types of insomnia.

Insomnia is a prevalent neurological disorder in the United States, with more than 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% of the adult population reports that they have experienced insomnia every night or almost every night within the past year. Despite this widespread prevalence, insomnia remains a disorder with high unmet medical needs, including the ability to maintain sleep throughout the night without next-day residual effects.

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 more selectively than the currently marketed non-benzodiazepines at the specific subtype of GABA-A receptors within the brain believed to be responsible for promoting sleep.

Source: Neurocrine Biosciences, Inc.

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