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Positive Results Reported From Second Phase III Clinical Trial of Indiplon

SAN DIEGO, April 21 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced positive results from the Company's second Phase III clinical trial with an immediate release formulation of indiplon, achieving statistically significant results in both primary and secondary endpoints of sleep initiation with no evidence of next day residual effects in 200 adult patients with Chronic Primary Insomnia. Results demonstrated that the immediate release formulation of indiplon was safe, well tolerated, and effective in these patients throughout the 35-day treatment period. The study was a randomized, double-blind, placebo- controlled, parallel group, multicenter Phase III clinical trial designed to assess the safety and efficacy of two dose levels of immediate release indiplon capsules (10 mg or 20 mg) in adult patients with Chronic Primary Insomnia. The primary endpoint was Latency to Persistent Sleep (LPS) as measured objectively by polysomnography (PSG), the endpoint for approval of currently marketed sedative hypnotics. The study was conducted in 19 sleep centers in the U.S. and patients received treatment on an in-patient and outpatient basis over a 35-day treatment period. In this study the immediate release formulation of indiplon demonstrated a statistically significant improvement in the primary endpoint of LPS at both dose levels relative to placebo on the first two nights after dosing as well as on nights 15 and 16 and nights 29 and 30 (see inserted table 1 for summary). Both doses of the immediate release formulation of indiplon were well tolerated. In addition, side effects for the indiplon groups were no different from placebo and there were no statistically significant differences in next day residual sedation detected by any of the three validated measurements, Visual Analogue Scale (VAS), Symbol Copy Test (SCT) and Digital Symbol Substitution Test (DSST), as compared with placebo.

_________________________________________________________________________ 35 Day Chronic Primary Insomnia Study with the immediate release formulation of indiplon _________________________________________________________________________ Intent to Treat (LPS) _________________________________________________________________________ DESIGN Placebo 10 mg 20 mg 3 nights PSG screen on placebo 2 nights PSG baseline on placebo 35 day randomized treatment _________________________________________________________________________ EFFICACY Days 1&2 2 night PSG 36.9 min 27.7 min** 27.1 min* Days 15&16 2 night PSG 39.9 min 30.4 min** 28.7 min* Days 29&30 2 night PSG 40.1 min 29.2 min** 24.9 min** _________________________________________________________________________ ADVERSE EVENTS 44% 35% 44% _________________________________________________________________________ NEXT DAY EFFECTS No statistically significant DSST difference at any dose, any SCT measurement or any time point VAS _________________________________________________________________________ * p Commenting on the clinical results, Dr. Martin Scharf, Director Tri-State Sleep Disorders Center and Clinical Professor at the Wright State University Department of Psychiatry said, "These safety and efficacy results with indiplon are impressive and confirm the results previously reported in Phase II studies in patients suffering from Chronic Primary Insomnia. These new data show a statistically significant effect for sleep initiation which was also sustained through four weeks of dosing using PSG measurement, a treatment effect that has not been consistently demonstrated by other sedative hypnotic agents. Indiplon demonstrated predictable efficacy and safety results without next day residual effects in this patient population, a critical factor in treating chronic patients who have difficulty in falling asleep, over the long term."

"We are pleased with these results in our second completed Phase III study and the first reported for Chronic Primary Insomnia. With this trial, indiplon has been studied in over 3000 subjects and patients and the results have been consistently positive. Neurocrine's indiplon program involves over 6000 adult, elderly, male, and female subjects and will include patients with up to one year of treatment. Our Phase III program alone will have data from over 4000 patients with different types of insomnia," said Dr. Henry Pan, Executive Vice President and Chief Medical Officer for Neurocrine Biosciences.

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 multiple Phase III safety and efficacy trials to support a New Drug Application (NDA) registration expected in early 2004 for indiplon for multiple indications associated with insomnia.

Indiplon is a unique non-benzodiazepine sedative hypnotic that acts on a specific site of the GABA-A receptor. It is through this mechanism that the currently marketed non-benzodiazepine therapeutics also produce their sleep- promoting effects. However, indiplon has been shown to be more potent than the currently marketed non-benzodiazepines at the specific subtype of receptors within the brain believed to be responsible for promoting sleep.

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.

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