Neurocrine Reports Additional Positive Results From Phase III Chronic Insomnia Trial
Indiplon Shows No Evidence of Rebound Insomnia or Withdrawal
SAN DIEGO, May 19 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that indiplon shows no evidence of rebound insomnia or withdrawal in a Phase III clinical trial with two doses (10 mg and 20 mg) of the immediate release formulation of indiplon in 200 patients with Chronic Primary Insomnia. Along with previously reported efficacy and safety results, this study was designed to evaluate the potential for rebound insomnia and withdrawal effects after discontinuation of indiplon after 35 consecutive nights of treatment.
Rebound insomnia is an increase in the time it takes to fall asleep upon cessation of treatment as compared to the time to fall asleep prior to the initiation of treatment. In this study, patients were evaluated by using continuous eight hours of polysomnography (PSG) recordings in sleep laboratories to assess evidence of rebound insomnia for two nights while on placebo after the 35-night treatment period. Results demonstrated that there was no evidence of rebound insomnia at either indiplon dose using the primary measure which compared patient's Latency to Persistent Sleep (LPS) on nights 36 and 37 (visit seven) to LPS during the pretreatment visit (visit three). In addition, no evidence of rebound insomnia was seen on any secondary measures comparing LPS during visit seven to LPS on pretreatment visit two or to the mean of pretreatment visits two and three.
There was also no evidence of withdrawal upon treatment discontinuation using the standard validated Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ). The BWSQ consists of 20 items and is designed to assess symptoms experienced by patients at any time during administration of, or withdrawal from, benzodiazepine or benzodiazepine-related compounds. The symptom questionnaire was administered on the last day the patient was on treatment as well as on the first two days post treatment. Post treatment BWSQ scores were compared to treatment BWSQ scores. No difference was seen in the mean change in score for both doses on either post-treatment day as compared with placebo.
Neurocrine recently reported positive efficacy and safety results from this Phase III clinical trial with the immediate release formulation of indiplon, achieving both primary and secondary endpoints without evidence of tolerance or next day residual effects in 200 adult patients with Chronic Primary Insomnia. 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.
"We are pleased with these additional results in our recently reported Phase III Chronic Primary Insomnia trial that demonstrate that the immediate release formulation of indiplon did not show evidence of rebound insomnia, tolerance, withdrawal or next day residual effects in this, the second completed Phase III study and the first reported for Chronic Primary 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) submission expected in early 2004 for indiplon for multiple indications associated with insomnia.
Indiplon is a unique non-benzodiazepine 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 is 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.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, diabetes, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, autoimmunity and certain female and male health disorders. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at neurocrine.com .
In addition to historical facts, this press release contains forward- looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward looking statements are risks and uncertainties associated with Neurocrine's indiplon development program and business and finances including, but not limited to, risk that indiplon will not successfully proceed through Phase III clinical trials or that Phase III clinical trials will not show that it is safe and effective in treating humans; determinations by regulatory and governmental authorities; our reliance on corporate collaborators for commercial manufacturing and marketing and sales activities; uncertainties relating to patent protection and intellectual property rights of third parties; impact of competitive products and technological changes; availability of capital and cost of capital; and other material risks. A more complete description of these risks can be found in the Company's Form 10K for December 31, 2002 and the Company's most recent report on Form 10Q. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
SOURCE Neurocrine Biosciences, Inc. |
