July 2009 Archives

The Honorable G. K. Butterfield, Jr., Democrat of North Carolina, along with 8 other House Representatives have introduced the "DON'T LET THE BED BUGS BITE ACT OF 2009" to establish a grant in support of states efforts to root out the ever increasing Bed Bug problem that is sweeping the nation. At the same time, Fairy Tales Consumer Products has released the first and only non-toxic Bed Bug eliminator spray that is approximately 100% effective in eradicating bed bugs at home and during travel, called Sleep-Tite, Don't Let the Bed Bugs Bite.

"While so many people are suffering from the resurgence in the pesky Bed Bugs, they are more than just a nuisance as they leave bites that can get infected," according to Risa Barash, Executive Director of Fairy Tales, "and cause an allergic reaction. While they aren't known to spread disease in humans, they can cause large itchy bites up to 8 inches across, blister-like skin inflammations, skin rashes similar to hives and groups of small swollen sacs of pus. They are just unattractive, disgusting and they're turning up everywhere," according to Barash.

"High cost treatments are not the best treatments they just cost a lot," continued Barash, "exterminators charge up to thousands of dollars where for under $20 you can have a safe, pesticide free, non-toxic solution that solves the problem at home, during travel and without breaking the bank." The Sleep-Tite formula has been proven effective in studies showing that 94% were dead within 60 seconds with the remaining killed after subsequent sprays.

SOURCE Fairy Tales Hair Care, Inc.

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT), a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, announced today that Glenn A. Oclassen, President & Chief Executive Officer, is scheduled to present at the BMO Capital Markets Healthcare Conference in New York City on Wednesday, August 5, 2009 at 4:00 p.m., Eastern Time.

An audio webcast of the presentation will be available at www.transcept.com. The audio replay of the presentation will be available at the same location through September 4, 2009.

About Transcept Pharmaceuticals (TSPT)

Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience. Its lead product candidate, Intermezzo(R) (zolpidem tartrate sublingual tablet), has the potential to be the first prescription sleep aid specifically approved for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. For further information, please visit the company's website at www.transcept.com.

About Intermezzo(R)

Intermezzo(R) (zolpidem tartrate sublingual tablet), the lead Transcept product candidate, has the potential to be the first prescription sleep aid specifically approved for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. Intermezzo(R) is a sublingual low dose formulation of zolpidem, the active agent most commonly prescribed in the United States for the treatment of insomnia. Intermezzo(R) uses approximately one-quarter to one-third of the dose of active drug contained in currently marketed zolpidem-based sleep aids, in a formulation designed to promote rapid sublingual absorption. As compared to placebo, two Phase 3 clinical studies of Intermezzo(R) showed a statistically significant reduction in the time it took patients to return to sleep after a middle of the night awakening, and there were no significant residual effects upon awakening four hours after dosing. Transcept believes that Intermezzo(R), by combining the reduced zolpidem dose with administration only on those nights when a middle of the night awakening actually occurs, has the potential to reduce unnecessary sedative-hypnotic exposure.

The U.S. Food and Drug Administration (FDA) has established October 30, 2009 as its target date under PDUFA (the Prescription Drug User Fee Act) to take action on its review of the New Drug Application (NDA) for Intermezzo(R). Transcept is actively pursuing patents to protect Intermezzo(R) in the United States and key non-U.S. markets, and, as part of the NDA submission, has requested that the FDA grant three years of Hatch-Waxman marketing exclusivity to Intermezzo(R).

About Middle of the Night Awakenings

Waking up during the night is the most frequent insomnia symptom reported in the general population. Based on a recently published epidemiological study of nearly 9,000 individuals, the Stanford Sleep Epidemiology Research Center has estimated that about one-third of adults in the United States experience middle of the night awakenings at least three times each week. The study concluded that more than 90 percent of those subjects who experienced middle of the night awakenings reported that this insomnia symptom persisted for at least six months, and approximately 11 percent had consulted a physician in regard to this sleep condition. In the Stanford study, fewer than 25 percent of those experiencing middle of the night awakenings reported difficulty going to sleep at bedtime. According to IMS Health, the overall U.S. market for prescription sleep aids was approximately $4.0 billion in 2008.

SOURCE Transcept Pharmaceuticals, Inc.

From March 31 to July 14, a six-man international crew called an isolation chamber in Moscow their home. The crew, composed of four Russians and two Europeans, simulated a 105-day Mars mission full of experiments and realistic mission scenarios, including emergency situations and 20-minute communications delays.

U.S. participation in the mission consisted of three research teams with experiments evaluating solutions to conditions that impact work performance. The projects evaluated lighting interventions to counter sleep disruption due to shift work or long hours, tested two objective methods of measuring the impact of stress and fatigue on performance, and assessed interactions between crew members and mission control. The three projects were funded by the Houston-based National Space Biomedical Research Institute (NSBRI).

"The mission allowed us to look at the feasibility of certain technologies developed for improving performance by deploying them in an extremely demanding work environment. In this realistic setting, will crews use the technologies and will we get good data?" said Dr. David F. Dinges, leader of the NSBRI group funded from University of Pennsylvania School of Medicine and Rutgers. "Additional goals were to see how different mission situations affected the various performance measures and to evaluate whether the interventions could indeed improve performance."

The 105-Day Mars Mission, a partnership between the Russia's Institute of Biomedical Problems and the European Space Agency, is the precursor to a 520-Day mission scheduled for 2010. The isolation facility consists of several interconnected, modules containing medical and scientific research areas, living quarters, a kitchen, greenhouse and exercise facility.

For researchers, the opportunity to run experiments in this type of environment was invaluable. "We've done experiments in the sleep lab to test the efficacy of lighting interventions, but that is a highly controlled environment," said Dr. Charles A. Czeisler, leader of the NSBRI project funded from Harvard Medical School, Brigham and Women's Hospital, and University of Colorado. "By transitioning studies into an operational environment, like the 105-Day Mission, we have the opportunity to learn how to best deploy interventions in a realistic mission setting. This analog is a great intermediate step before implementation on an actual spaceflight."

Participation from the crew and mission controllers was excellent. All three NSBRI projects received data throughout the mission. Final data will be received in the coming weeks, and the teams will begin detailed data analysis.

"These tests and interventions have an impact beyond the space program," Dinges said. "Many people work night shifts and in high-stress, confined environments that require alertness, such as power plant control rooms, railroad systems, hospitals, military operations, and fire and rescue situations. The things that we are learning here about how to enhance performance will be useful in many work environments."

NSBRI Project Overviews

Lighting Intervention Study (Dr. Charles A. Czeisler, lead investigator): The study compared two different wavelengths of light (in the green spectrum) during night-shift work with a control lighting condition (in the red spectrum). Crew members and mission control personnel participated. The experiment, which replicated studies done in sleep laboratories, examined whether exposure to green-enriched light will help sustain job performance in the middle of the night and when participants have been awake for a long time. The study looked at the impact of the light on melatonin, the body's sleep-promoting hormone. Additional data were collected for the study with participants taking performance tests, wearing watch-like devices that track sleep/wake periods, completing sleep and work logs, and submitting urine and saliva samples.

"Based on previous laboratory studies, we anticipate that during exposure to the shorter wavelength green light that melatonin will be significantly suppressed, resulting in better performance during overnight work," Czeisler said. "The findings will have direct application to night-shift workers."

Monitoring the Impact of Fatigue and Stress on Work Performance (Dr. David F. Dinges, lead investigator): The project tested two novel, unobtrusive, objective methods for monitoring impact of fatigue and stress on work performance. Crew members and mission control personnel participated. One test involved the feasibility of "reading the face" through use of an optical computer recognition system that monitored facial expressions, tracking the shape and movements of the face in three dimensions. Video was taken during brief cognitive tests, to detect the presence of stress, fatigue and negative affect, and will be used to determine the extent to which this approach was feasible during the mission.

The second performance measure used 3- and 10-minute laptop-based Psychomotor Vigilance Tests to detect changes in basic performance involving attention, response speed and impulsivity. The tests require the user to watch for a visual signal and respond quickly and accurately when it appears. Participants took the tests twice daily during day and night work. The tests have been validated in other settings for sensitivity to reduced alertness caused by a variety of factors in spaceflight (e.g., restricted sleep, night-shift work).

Crew Interactions and Autonomy (Dr. Nick Kanas, lead investigator): The study evaluated the mood, interpersonal interactions and performance of crew members and mission control personnel. The groups were studied under two conditions: low crew autonomy (where the work schedule was planned by mission control) and high crew autonomy (where the crew plan and troubleshoot their own work schedule). Through the use of a weekly questionnaire, the project will evaluate the experiment's impact on mission control and on the crew-ground relationship.

"The data gathered on the relative benefits of high versus low autonomy conditions during manned space missions will have relevance not only for future expeditions to the moon and Mars, but also to current on-orbit International Space Station missions," said Dr. Nick Kanas, leader of the NSBRI group funded at University of California, San Francisco.

Detailed summaries of each project are available on NSBRI's Russian Chamber Study Web page (http://www.nsbri.org/Research/105-DayRussianChamberStudy.html).

SOURCE National Space Biomedical Research Institute

New Strategic Direction and Marketing Campaign Encourage People to Sleep Healthy and 'Replace Every Eight'

Sit 'n Sleep, the mattress superstore dedicated to providing a good night's sleep to millions of Southern Californians, today launched a new campaign focused on educating consumers around the link between the right mattress and improved sleep health and well-being. Widely-known for its ubiquitous advertising campaigns touting the best prices in town, Sit 'n Sleep's new strategic direction and corresponding advertising campaign encourage consumers to consider how purchasing the right mattress for your body-type and personal needs impacts one's physical and mental condition, and also illuminates the little-known fact that old mattresses can adversely affect overall health. All Sit 'n Sleep stores now also feature body diagnostic technology, computerized sensors that measure each customer's unique body profile and custom fit them with just the right mattress.

"Your mattress is one of the primary factors impacting whether or not you get a healthy night's sleep, and healthy sleep means a healthy body," said Larry Miller, founder, president and CEO of Sit 'n Sleep. "Recent scientific studies show that too little sleep can impact your health, your sanity and even your marriage, and we are dedicating our time to educating consumers on how the mattress they sleep on every day impacts their sleep patterns. What's more, many don't know that old mattresses actually breed uninvited guests in the bed; millions of dust mites that build up over the years. It's time for us to stand up and say 'you spend a third of your life on a mattress - shouldn't you be certain it's taking care of you?'"

Sleep and Health:

The quality of one's mattress has been referenced as a primary factor affecting the quality of one's sleep, which impacts overall health and well-being. Recent reports(1) demonstrate how a good night's sleep means better health, better mental and emotional stability, stronger work performance and a better marriage and sex life. Poor sleep health has been tied to specific medical conditions such as obesity, high blood pressure, depression, irregular hormone production, a weakened immune system, memory lapses, constant irritability and decreased concentration and reaction times.

Sleep and blood pressure: According to a 2009 report published in the Archives of Internal Medicine, sleep deprivation in middle aged people leads to high blood pressure levels.

Weight gain: According to a released by Merck Research Labs in 2009, there appears to be a link between sleep and weight control, with some studies indicating that sleep disruption can increase weight gain.

Depression: A study released in 2009 from Columbia University supports the idea that inadequate sleep could lead to depression.

Performance at work: Studies estimate that sleep deprivation currently costs U.S. businesses nearly $150 billion annually in absenteeism and lost productivity, according the Better Sleep Council 2007 Better Sleep Month survey.

Sex Life: Scientists in Israel released a 2008 study conducted at the Technion Sleep Center, which found that men who have less sleep than is medically required experience a substantial decrease in their sexual drive.

Marriage/relationships: A study related in 2009 by the University of Arizona found that how well a couple sleeps affects how the relationship functions the following day.

Academic performance: A study recently released from Hendrix College in Arkansas found that poor sleep was linked to poorer academic performance.

SOURCE Sit 'n Sleep

"One sleep myth I've heard too often is that people think they can have alcohol or wine with their sleep aid, to help them get to sleep faster. Click around in the video to find out more.

Some people even think that alcohol is their sleep aid. It's okay to enjoy a glass of wine every now and then - however, even though alcohol can provide a sedating effect, it actually causes more awakenings during the night.

Sleep medications should not be used with alcohol or other drugs. Take your medication safely and appropriately. In addition, avoid nicotine altogether, and avoid caffeine close to bedtime."

Klickable hotspots:

 - Dr. Donnica: Donnica Moore, MD, President of the Sapphire Women's Health Group and Women's Health Expert.

  - Glass of wine: Enjoy your alcohol responsibly. Be smart - don't ever use it with your sleep aid.

  - Prescription Bottle: Are you following your healthcare professional's instructions about how, when and with what to take this?

  - Alarm clock: If you have not been having a good night's sleep, it's time for a wakeup call! Write down your sleep symptoms in a sleep diary to share with your healthcare professional.

  - Pillow: You might think that if you don't get enough sleep during the week, you can just catch up over the weekend, but you really should try to stick to the same sleep schedule all week long.

Source: National Sleep Foundation

"Can you identify the things in your bedroom that might get in the way of a good night's sleep? Click around in this bedroom to test your sleep smarts.

Exercise can be helpful for good sleep, especially when done regularly in the morning or afternoon, and not too close to bedtime. If you don't exercise regularly, add good sleep to a long list of reasons why you should take up the habit.

It's smart to avoid strenuous exercise right before sleep and even up to three hours before bedtime. If you've been exercising close to bedtime and having trouble falling asleep or staying asleep, try to pump your iron earlier in the day.

Doing work, watching TV and using the computer, both close to bedtime and especially in the bedroom, hinders quality sleep. Violent shows, news reports and stories before bedtime can be agitating. The sleep environment should be used only for sleep and sex.

Here's some tips for sleeping smart:

  - Establish a regular bed and wake time.

  - Avoid nicotine altogether and avoid caffeine close to bedtime.

  - Avoid alcohol.

  - Exercise regularly, but complete the workout at least three hours before bedtime.

  - Establish a consistent, relaxing "wind-down" bedtime routine.

  - Create a sleep-conducive environment that is dark, quiet and comfortable.

  - Discuss the appropriate way to take any sleep aid with a healthcare professional."

Klickable hotspots:

  - TV: Watch your sleep habits, not the TV. Come up with a smart sleeping schedule and do your TV-watching outside of the bedroom.

  - Weights/Exercise Equipment: Diet and exercise are important, but so is sleep. If you have insomnia, sometimes sleep can feel like an uphill battle. Before you give up, make an appointment and talk to your healthcare professional about ways to help you fall or stay asleep.

  - Laptop: Warning: your bedroom is now officially a "no-work" zone. Wind down before bed, stop working.

  - Bed: Your sleep environment should only be used for sleep and sex.

  - Lamp: As part of your wind down routine, dim the lights. Trying to go to sleep after being around bright lights will make sleep more difficult.

  - Fan: Whether you prefer it warm or cool, your bedroom should be comfortable for you.

Curtains: Create a sleep-conducive environment that is dark, quiet and comfortable.

Source: National Sleep Foundation

Cephalon, Inc. (Nasdaq: CEPH) today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval of NUVIGIL(R) (armodafinil) Tablets [C-IV] for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. Jet lag disorder is an acute condition that occurs when a person's internal body clock becomes disrupted as a result of rapid travel across several time zones. Based on U.S. Bureau of Labor Statistics findings, an estimated 70 million American travelers experience jet lag annually. Currently, there are no FDA-approved medications to improve wakefulness in travelers who experience the excessive sleepiness commonly associated with long flights.

"This supplemental New Drug Application for a new use of NUVIGIL is another important milestone for Cephalon. We hope that this will be the first of many new indications for NUVIGIL over the next five years," said Dr. Lesley Russell, Chief Medical Officer and Executive Vice President at Cephalon.

The NUVIGIL sNDA for the treatment of excessive sleepiness associated with jet lag disorder is based on data from a Phase 3 study, recently presented at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies in Seattle, Washington. The data from this novel placebo-controlled pivotal study, which involved overseas air travel, included an evaluation of the efficacy and safety of NUVIGIL (50 or 150 mg/day) in 427 healthy men and women who all had experienced jet lag symptoms at least once during the previous five years. Clinical efficacy was evaluated using two primary endpoints: an objective assessment -- the Multiple Sleep Latency Test (MSLT), and a subjective assessment -- the Patient Global Impression of Severity (PGI-S). Patients taking NUVIGIL (150 mg/day) showed a statistically significant improvement over placebo as measured by the MSLT [p<0.0001] and the PGI-S [p<0.05]. The most common adverse events associated with NUVIGIL treatment (five percent or greater) were headache, nausea, diarrhea, and palpitations.

About NUVIGIL

NUVIGIL, the longer-lasting form of modafinil, was launched in the United States in June 2009 and is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy. NUVIGIL is not currently indicated for the treatment of jet lag disorder or its associated symptoms. The NUVIGIL label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, that has been reported in adults and children taking modafinil, a racemic mixture of S- and R-modafinil (the latter is armodafinil, the active ingredient in NUVIGIL). NUVIGIL is not approved for use in pediatric patients for any indication.

The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness, and insomnia. Full prescribing information for NUVIGIL is available at www.NUVIGIL.com.

SOURCE Cephalon, Inc.