Transcept Pharmaceuticals Receives Complete Response Letter From FDA On Intermezzo R New Drug Application
Transcept Pharmaceuticals (Nasdaq: TSPT) announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). The NDA, submitted by Transcept in September 2008, seeks approval to market Intermezzo® for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. In the Complete Response Letter the FDA stated that it believes Transcept has submitted substantial evidence of effectiveness for the use of Intermezzo® in the as-needed treatment of insomnia characterized by difficulty returning to sleep after awakening in the middle of the night. The FDA further recognized that the Intermezzo® data submitted by Transcept did not indicate significant next day residual effects. However, the FDA indicated that the intended use of Intermezzo® in the middle of the night represents a unique insomnia indication and dosing strategy for which safety has not been previously established.
NECT (Nifurtimox-Eflornithine Combination Therapy), the first new treatment in 25 years against Human African trypanosomiasis (HAT) or sleeping sickness, is now available. Endemic countries have now begun the process of ordering the new combination treatment and kits through the World Health Organization (WHO). Developed by DNDi and its partners, NECT cuts the cost of treatment by half and significantly reduces the burden on health workers. The announcement was made today at the International Scientific Council for Trypanosomiasi Research and Control (ISCTRC), in Kampala, Uganda. "Thanks to an innovative partnership and the hard work of health workers, researchers, and specialists from endemic countries, industry and academia, a new treatment is now available to treat one of the most neglected disease in Africa. Not only is this new therapy more adapted to patient needs in remote areas, but it also cuts the cost of drugs, hospitalization and transport, " said Dr Bernard PÃ coul, Executive Director of Drugs for Neglected Diseases (DNDi).
A study in the Nov.1 issue of the journal Sleep shows that sleep deprivation causes some people to shift from a more automatic, implicit process of information categorization (information-integration) to a more controlled, explicit process (rule-based). This use of rule-based strategies in a task in which information-integration strategies are optimal can lead to potentially devastating errors when quick and accurate categorization is fundamental to survival. Results show that sleep deprivation led to an overall performance deficit on an information-integration category learning task that was held over the course of two days. Performance improved in the control group by 4.3 percent from the end of day one to the beginning of day two (accuracy increased from 74 percent to 78.3 percent); performance in the sleep-deprived group declined by 2.4 percent (accuracy decreased from 73.1 percent to 70.7 percent) from the end of day one to the beginning of day two. According to co-principal investigators W.
A study in the Nov.1 issue of the journal Sleep shows that retirement is followed by a sharp decrease in the prevalence of sleep disturbances. Findings suggest that this general improvement in sleep is likely to result from the removal of work-related demands and stress rather than from actual health benefits of retirement. Results show that the odds of having disturbed sleep in the seven years after retirement were 26 percent lower (adjusted odds ratio of 0.74) than in the seven years before retiring. Sleep disturbance prevalence rates among 14, 714 participants fell from 24.2 percent in the last year before retirement to 17.8 percent in the first year after retiring. The greatest reduction in sleep disturbances was reported by participants with depression or mental fatigue prior to retirement. The postretirement improvement in sleep also was more pronounced in men, management-level workers, employees who reported high psychological job demands, and people who occasionally or consistently worked night shifts.
Sleep apnea is a common disease that affects millions of people all over the world, and if left undiagnosed and untreated can cause serious health complications. GE Sensing & Inspection Technologies (NYSE: GE) has developed the Nova Pressure Amplified (NPA) series of pressure sensors for medical devices. Small and effective, the NPA is a critical component in creating cost-effective sleep apnea monitors that are more accurate and reliable than those currently on the market. "The NPA pressure sensor series ensures that new sleep apnea and respiratory monitors have the best price performance available for critical care and home-use markets, " said Brian Wirth, Global Product Manager at GE Sensing & Inspection Technologies. The NPA series provides a cost effective solution for medical applications that require calibrated, accurate and stable pressure measurement in one of the smallest packages available on the market today. The small size, position sensitivity and surface mount packaging help original equipment manufacturers (OEM) reduce external component costs, which improves overall system reliability.
New research shows that Caucasian women may suffer from restless legs syndrome (RLS), a sleep disorder characterized by the strong urge to move the legs, up to four times more than African-American women. The study, presented at CHEST 2009, the 75th annual international scientific assembly of the American College of Chest Physicians (ACCP), found that, overall, non-African-American (NAA) patients experienced RLS four times more often than African-Americans (AA). Furthermore, 2 out of 5 Caucasian women were found to have RLS, nearly four times the incidence of RLS in African-American women and the highest incidence among all groups. "There are significant ethnic differences in the prevalence of restless legs syndrome, but the exact causes of higher prevalence among Caucasians are unknown, " said Ammar Alkhazna, MD, University of Missouri, Kansas City, MO. "This likely reflects a combination of factors, including a genetic predisposition to RLS, diet -- including iron intake -- medications, and possibly culture.
Golfers who undergo treatment for sleep apnea may improve their golf game as well as their overall health, shows new research. A new study presented at CHEST 2009, the 75th annual international scientific assembly of the American College of Chest Physicians (ACCP), found that golfers with obstructive sleep apnea (OSA) who received nasal positive airway pressure (NPAP) for their disorder improved their daytime sleepiness scores and lowered their golf handicap by as much as three strokes. Researchers suggest that the possibility of improving your golf game may be a significant motivator to improve NPAP compliance rates among golfers. "More so than many sports, golf has a strong intellectual component, with on-course strategizing, focus, and endurance being integral components to achieving good play, " said Marc L. Benton, MD, FCCP, Atlantic Sleep and Pulmonary Associates, Madison, NJ. "OSAS can lead to daytime sleepiness, fatigue, and cognitive impairment, all side effects which can negatively impact a person's ability to golf to the best of one's ability.
There is a high prevalence of nocturnal teeth grinding, or bruxism, in patients with obstructive sleep apnea (OSA), particularly in Caucasians. New research presented at CHEST 2009, the 75th annual international scientific assembly of the American College of Chest Physicians (ACCP), found that nearly 1 in 4 patients with OSA suffers from nighttime teeth grinding; this seems to be especially more prevalent in men and in Caucasians compared with other ethnic groups. It is estimated that 8 percent of the general US population suffers from bruxism, a condition frequently associated with a preexisting dental or jaw disorders, as well as stress. "The relationship between obstructive sleep apnea and sleep bruxism is usually related to an arousal response. The ending of an apneic event may be accompanied by a number of mouth phenomena, such as snoring, gasps, mumbles, and teeth grinding, " said Shyam Subramanian, MD, FCCP, Baylor College of Medicine, Houston, TX. "Men typically have more severe sleep apnea, and perhaps may have more arousal responses, which may explain the higher prevalence of teeth grinding in men.
Bedwetting is a common childhood condition. It occurs when there is an accidental loss of urine during sleep. Bedwetting is also known as nocturnal enuresis or nighttime incontinence. It is normal in children who are under five years old. At this age, nighttime bladder control may not be established. Bedwetting is the most common pediatric-health issue. Studies show that parents become worried too quickly because they expect children to stay dry too early. Most girls can stay dry by age six and most boys stay dry by age seven. According to Medilexicon's medical dictionary, Enuresis is "urinary incontinence during sleep." Bedwetting is often caused by an overactive bladder, but it canÂ be theÂ result of problems with the development of the bladder. It canÂ also be due to a neurological disorder (disorders of the brain and nervous system). There are two types of bedwetting: Primary nocturnal enuresis: persistent, involuntary bedwetting during sleep in a childÂ aged fiveÂ or over. Secondary nocturnal enuresis: in some cases bedwetting comes backÂ after a dry period of at least six months.
Children With Asthma May Benefit From Reduction in Daily Steroids (#9114) Children with status asthmaticus, those who experience prolonged and serious asthma attacks, may safely be able to reduce their daily corticosteroid dose. Researchers from Kosair Children's Hospital in Kentucky conducted before and after chart reviews of 292 patients younger than 18 years who were hospitalized with status asthmaticus. Eligible patients had received methylprednisolone, prednisolone, or prednisone. Steroid dosing for group 1 (152 patients) was 1 mg/kg/dose every 6 hours (maximum of 240 mg/day) and 0.5 to 1 mg/kg/dose every 12 hours (maximum of 60 mg/day) for group 2 (141 patients). The average length of hospital stay for was 2.01 days for group 1 and 1.98 days for group 2, suggesting there was no effect on length of stay. Researchers conclude that decreasing the daily dose of systemic corticosteroids for status asthmaticus does not affect the length of hospital stay. High-Dose Inhaled Albuterol Associated With Metabolic Acidosis (#8423) Patients with severe acute asthma may be at a higher risk of developing metabolic acidosis, an excess of acid in the blood.