Transcept Pharmaceuticals Scheduled To Meet With FDA To Discuss Intermezzo R Complete Response Letter
Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). As previously announced, the Complete Response Letter, received by Transcept on October 28, 2009, indicated that the FDA could not approve the NDA in its present form. The NDA 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. Following the receipt of official FDA minutes of the meeting, Transcept plans to provide an update on its discussions with the FDA and the status of the anticipated Intermezzo® NDA resubmission. About Transcept Pharmaceuticals, Inc. Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience.
Researchers have found that 43 percent of patients undergoing chemotherapy for cancer in a clinical trial met the clinical criteria for insomnia syndrome and an additional 37 percent had insomnia symptoms, suggesting that the majority of patients (80 percent) suffer from sleep difficulties. This rate is approximately two to three times higher than that seen in the general population. Insomnia syndrome is defined as difficulty sleeping three or more times per week for at least a month, and can cause significant distress or impairment in daytime functioning. Prior studies have identified increases in sleep disturbances among people with cancer; this is the first to show an elevated risk of insomnia syndrome in people undergoing active cancer treatment with chemotherapy. "Our research shows that insomnia is very common among patients undergoing cancer treatment and is likely under-diagnosed. The good news for people with cancer is that there are many effective treatment options that can help, " said Oxana Palesh, PhD, MPH, lead author and research assistant professor in the Departments of Radiation Oncology and Psychiatry at the University of Rochester Medical Center in New York.
Falls among elderly people are significantly associated with several classes of drugs, including sedatives often prescribed as sleep aids and medications used to treat mood disorders, according to a study led by a University of British Columbia expert in pharmaceutical outcomes research. The study, published Nov. 23 in the Archives of Internal Medicine, provides the latest quantitative evidence of the impact of certain classes of medication on falling among seniors. Falling and fall-related complications such as hip fractures are the fifth leading cause of death in the developed world, the study noted. Antidepressants showed the strongest statistical association with falling, possibly because older drugs in this class have significant sedative properties. Anti-psychotics/neuroleptics often used to treat schizophrenia and other psychoses and benzodiazepines such as valium were also significantly associated with falls. "These findings reinforce the need for judicious use of medications in elderly people at risk of falling, " says principal investigator Carlo Marra, a UBC associate professor of Pharmaceutical Sciences.
The kids may be sleeping soundly this season with "visions of sugar plums in their heads, " but almost half of the nation's moms and dads (44%) say they are worried about being able to afford the holidays this year, with one in six Americans (17%) expecting to lose sleep due to holiday-induced stress. The findings are part of a national year-end survey - the SleepBetter.org Holiday Slumber Index, which measures the impact of the holidays on Americans' sleep patterns. According to the survey, parents are most susceptible to sleep changes. Two in three (66%) of mothers and fathers, for example, say they will get six or fewer hours of sleep the night before gift-giving. And while 11% of households without kids say that holiday stressors cause them to lose sleep, more than twice as many parents (27%) indicate that this is the case. "There are many ways that the holidays throw us off our sleep patterns, " said Dan Schecter, vice president of consumer products at Carpenter Co., and creator of SleepBetter.
The National Institutes of Health is launching a $37 million program that will use findings from basic research on human behavior to develop more effective interventions to reduce obesity. The program, Translating Basic Behavioral and Social Science Discoveries into Interventions to Reduce Obesity, will fund interdisciplinary teams of researchers at seven research sites. Investigators will conduct experimental research, formative research to increase understanding of populations being studied, small studies known as proof of concept trials, and pilot and feasibility studies to identify promising new avenues for encouraging behaviors that prevent or treat obesity. The program is led by the National Heart, Lung, and Blood Institute (NHLBI), in partnership with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Cancer Institute (NCI), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the Office of Behavioral and Social Sciences Research (OBSSR).
Repeated use of the drug popularly known as "ecstasy" significantly raises the risk of developing sleep apnea in otherwise healthy young adults with no other known risk factors for the sleep disturbance, a new study by Johns Hopkins scientists suggests. The finding is the latest highlighting the potential dangers of the amphetamine-style chemical, currently used illegally by millions of people in the United States. The Johns Hopkins scientists note that sleep apnea itself can lead to an assortment of health problems, including a decline in cognitive function, an increased risk of diabetes, and an increased risk of death from heart disease. "We know that abusing drugs can have numerous harmful effects. Our findings show yet another reason not to use ecstasy, " according to lead researcher Una D. McCann, M.D. Users claim the drug enhances intimacy, diminishes anxiety, and facilitates some forms of psychotherapy. The team led by McCann, professor in the Department of Psychiatry at the Johns Hopkins University School of Medicine, previously linked ecstasy, or methylenedioxymethamphetamine (MDMA), to a variety of neurological problems, including subtle cognitive deficits, impulsive behavior, and altered brain wave patterns during sleep.
It is estimated that almost 2 million kids in the United States alone suffer from obstructive sleep apnea (OSA) and may require continuous positive airway pressure (CPAP) therapy. This number has increased more than 10 times in the last 30 years, thanks mainly to the nation's obesity epidemic. However, pediatric OSA appears to be an underserved and misunderstood market, reports the American Academy of Sleep Medicine (AASM). That's because primary care physicians often misdiagnose daytime sleepiness as related to bedwetting, nightmares or some other common childhood issue - not OSA. That is expected to change as physicians become more aware of OSA in children and there will be a bigger need for comfortable treatment methods. Pediatric CPAP mask/interface options are very limited. Until now, the only available options were traditional "over the nose" nasal masks, that make a large percentage of kids feel claustrophobic and not cooperate with CPAP therapy despite parental support. This constraint has largely now been eliminated with the FDA 510(k) clearance of the Nasal-Aire®
Holiday time is upon us, and with it comes family trips, household visitors, home decorating chores, party planning, gift-shopping and -- of course -- all those extra bills to pay. All of this added stress can lead to sleepless nights, but it doesn't have to. SleepBetter.org, one of the premier sites on the web for sleep advice, is offering a series of tips to help ensure that holiday stress doesn't keep you from getting a good night's rest. According to well-known sleep expert and contributor to SleepBetter.org, Michael J. Breus, Ph.D, "Stress of any kind is a proven cause of sleep disorders and interrupted sleep patterns." "Your health is your most important asset and it takes good quality sleep to maintain it, " adds Breus. "Some studies also link poor sleep with increased susceptibility to ulcers, heart disease, obesity, depression and a host of age-related ailments. Sleep deprivation also is frequently cited as the cause of highway fatalities and other accidents." SleepBetter.
Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, announced that the company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia. Based on its review, the FDA has determined that the NDA cannot be approved in its present form. Somaxon previously received a Complete Response Letter for the NDA in February 2009, and it resubmitted the NDA in June 2009. In the most recent Complete Response Letter, the FDA stated that the Silenor NDA did not meet the approval standard for efficacy due to a lack of robustness of sustained subjective sleep maintenance efficacy in adults with primary insomnia. With respect to safety, the most recent Complete Response Letter did not raise any clinical safety issues.
Researchers at the University of Chicago have discovered a technique that is able to determine whether a child has obstructive sleep apnea (OSA) or habitual snoring by screening their urine. "These findings open up the possibility of developing a relatively simple urine test that could detect OSA in snoring children. This would alleviate the need for costly and inconvenient sleep studies in children who snore, only about 20 to 30 percent of whom actually have OSA, " said lead author David Gozal, M.D., professor and chairman of the pediatrics department at the University of Chicago. The study results are published in the December 15 issue of the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine. Dr. Gozal and researchers from University of Chicago and the University of Louisville studied 90 children who were referred to the sleep clinic to be evaluated for suspected sleep disordered breathing. They also recruited 30 healthy, non-snoring children from the community to serve as controls.