Cephalon Provides Update On Regulatory Review Of NUVIGIL For The Treatment Of Excessive Sleepiness Associated With Jet Lag Disorder
Cephalon, Inc. (Nasdaq: CEPH) announced that the U.S. Food and Drug Administration (FDA) has extended the action date to March 29, 2010, for its review of the supplemental New Drug Application (sNDA) for NUVIGIL® (armodafinil) Tablets [C-IV]. The sNDA is for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel. "We will continue to work closely with the FDA to assist them in completing their review of our application in a timely manner and do not anticipate any further delays beyond the March 29, 2010, action date, " said Dr. Lesley Russell, Chief Medical Officer at Cephalon.
Many alcoholic beverages contain byproducts of the materials used in the fermenting process. These byproducts are called "congeners, " complex organic molecules with toxic effects including acetone, acetaldehyde, fusel oil, tannins, and furfural. Bourbon has 37 times the amount of congeners that vodka has. A new study has found that while drinking a lot of bourbon can cause a worse hangover than drinking a lot of vodka, impairment in people's next-day task performance is about the same for both beverages. Results will be published in the March 2010 issue of Alcoholism: Clinical & Experimental Research and are currently available at Early View.
A widely used test for measuring nighttime blood pressure may interfere with patients' sleep, thus affecting the results of the test, reports a study in an upcoming issue of Clinical Journal of the American Society of Nephrology (CJASN). "Blood pressure (BP), measured during sleep correlates better with heart attacks and strokes compared to blood pressure measured in the doctor's office, " explains Rajiv Agarwal, MD (Indiana University and Veterans Affairs Medical Center, Indianapolis). "However, if blood pressure measurement disturbs sleep, then it may weaken the relationship between 'sleeping BP' and these cardiovascular events." Along with his data-manager, Robert Light, BS (also of Indiana University), Agarwal analyzed the results of 24-hour blood pressure monitoring in 103 patients with kidney disease.
Shift work exposures can accelerate metabolic syndrome (MetS) development among the large population of middle-aged males with elevated alanine aminotransferase (ALT). Elevated serum alanine aminotransferase (e-ALT) is a common abnormality of health examinations in middle-aged working populations. It is unavoidable nowadays that a large number of asymptomatic workers with e-ALT may be asked to do rotating shift work on 24 h production lines. In some previous studies, e-ALT and shift work had been independently assessed for their associations with MetS, which is associated with cardiovascular disease, one of the leading causes of death among working populations.
A study in the Dec. 15 issue of the Journal of Clinical Sleep Medicine indicates that significant associations exist between parent-reported insomnia symptoms and medical complaints of gastrointestinal regurgitation and headaches in young school-aged children. Results of multivariate regression analysis show that parent-reported insomnia was 3.3 times more likely in children with gastrointestinal regurgitation and 2.3 times more likely in children with headaches. Nineteen percent of children met the criteria for insomnia, which was defined as often having trouble falling asleep and/or waking up often in the night. Gastrointestinal regurgitation was reported in 7.
A study in the Dec. 15 issue of the Journal of Clinical Sleep Medicine shows that being overweight or obese increases the risk for developing obstructive sleep apnea (OSA) in adolescents but not in younger children. Results indicate that the risk of OSA among Caucasian adolescents 12 years of age and older increased 3.5 fold with each standard-deviation increase in body mass index (BMI) z-score, while the risk of OSA did not significantly increase with increasing BMI among younger children. According to the authors, the results suggest that the increase in risk among overweight and obese adolescents may result from developmental changes such as reductions in upper airway tone and changes to anatomic structures.