Neurocrine Biosciences Announces New Research Studies Presented at APSS Reveal Significant Under-Diagnosis of Insomnia
SAN DIEGO, June 12, 2007 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. announced today that results from several research studies on the impact of chronic primary and transient insomnia were presented this week at the Associated Professional Sleep Societies (APSS) Annual Meeting. APSS highlights show that insomnia is significantly under-diagnosed and puts a significant strain on the Healthcare System and Labor Force. New data presented at APSS demonstrates the significant impact insomnia has on daytime functioning including workplace productivity, health, mood and quality of life, regardless of the type of sleep difficulty experienced.
"This research demonstrates that the impact of sleep difficulties on sufferers and the healthcare system is significant. Mounting research confirms that insomnia is a condition to be taken seriously and suggests that treating insomnia properly from the outset could reduce its subsequent impact, cost and safety consequences," said Christopher O'Brien M.D., Senior Vice President of Clinical Development and Chief Medical Officer of Neurocrine Biosciences.
APSS Presentation Highlights: Study Demonstrates that Insomnia is Significantly Under-Diagnosed -- The purpose of this study was to examine the prevalence and clinical characteristics of subtypes of insomnia in the general population. -- According to a survey of 14,997 U.S. adults, 43.3% of respondents self-reported sleeping difficulties related to insomnia; compared to only 8.5% who met the more stringent Diagnostic and Statistic Manual of Mental Disorders IV (DSM-IV) criteria for primary insomnia by self-reported symptoms. -- Results found that DSM-IV insomnia appears to be under-diagnosed and under-treated. Additionally, there are a significant number of individuals with insomnia, who do not meet the DSM-IV criteria, and experience considerable daytime impairment and symptom frequency. Study Estimates Insomnia Costs at $13.5 Billion Annually in the U.S. Labor Force -- The objective of this study was to estimate the annual indirect costs in the U.S. Labor Force of DSM-IV diagnosed chronic primary insomnia. -- Results showed that the annual indirect cost of chronic primary insomnia in the U.S. labor force, as diagnosed by the DSM-IV, is estimated to be $13.5 billion which reflects absenteeism from work directly attributable to an insomnia diagnosis, and productivity losses attributable to the insomnia-related incidence of accidents and chronic illnesses (depression, alcohol and/or substance abuse/dependence) -- The authors concluded that a DSM-IV diagnosis of insomnia leads to considerable productivity losses in the U.S. labor force. Interventions to reduce the severity of chronic primary insomnia among U.S. workers could substantially reduce its indirect cost burden.
Pharmaceutical Treatment of Insomnia Reduces Overall Economic Costs of Insomnia
-- The objective of this study was to estimate the direct and indirect costs of treated and untreated insomnia in an employed population. -- Results showed that insomnia patients who were initially treated with a non-benzodiazepine hypnotic within two weeks of diagnosis had a much lower cost burden that those who were not treated for their insomnia. Demonstrating that treating insomnia was cost-effective relative to non-treatment, or delayed treatment.
Study Shows that Existing Next Day Impairment Measures May Not Capture True Impact of Insomnia
-- The goal of this study was to evaluate the commonly used tests of "next day functioning" in insomnia patients to determine if these tests were successful in measuring key impairment characteristics. -- The research identified impairment in several areas that were not identified by traditional tests of functioning. Examples include abstraction, organization/planning, time management, cognitive flexibility, judgment and problem solving. -- Researchers concluded that current measures of daytime functional impairment may not accurately assess key aspects of daytime functional impairment.
Increase in Medical Errors As a Result of Insomnia
Results of a new survey that found that insomnia was common in the nursing community, previously announced by Alertness Solutions, were presented at the APSS meeting. The authors concluded that more than one quarter of nurses surveyed suffered from insomnia. The survey conducted by Dr. Mark Rosekind, founder, president and chief scientist of Alertness Solutions, previous director of the Fatigue Countermeasures Program at the NASA Ames Research Center and sleep researcher at Stanford University also identified potential daytime consequences of insomnia that were common among nurses that may affect patient care including a significant increase in medication dispensing errors, charting deviations, and falling asleep unintentionally at work.
Neurocrine is developing indiplon for the treatment of insomnia. Indiplon was licensed from DOV Pharmaceutical in 1998. Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. The product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, endometriosis, irritable bowel syndrome, and pain. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at http://www.neurocrine.com.
In addition to historical facts, this press release may contain 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 business and finances in general as well as, risk and uncertainties associated with the Company's indiplon program and planned commercialization activities, including but not limited to; risk that we will be unable to resubmit the indiplon capsule NDA in a timely manner or at all; risk that regulatory authorities may refuse to accept the filing of our resubmission of the indiplon capsule NDA; risk that regulatory authorities may find our resubmission of the indiplon capsule NDA incomplete or insufficient or otherwise unapprovable or that approval may be delayed; risk that following approval of indiplon capsules, commercialization may be delayed for any of a number of reasons including market conditions and product supply; risk that we will not be able to independently commercialize indiplon capsules or find a marketing partner on reasonable terms or at all; risk that the indiplon capsule labeling granted by regulatory authorities may limit the commercial success of indiplon capsules; and risk relating to market acceptance of indiplon capsules following marketing approval; in addition to the other risks described in the Company's report on Form 10-K for the year ended December 31, 2006 and Form 10-Q for the quarter ended March 31, 2007. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
CONTACT: Investors, Elizabeth Foster of Neurocrine Biosciences,+1-858-617-7600; or Media, Liz Frank of WeissComm Partners, +1-212-301-7216
Web site: http://www.neurocrine.com/
Ticker Symbol: (NASDAQ-NMS:NBIX)
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Posted: June 2007