VIVUS, Inc. (Nasdaq: VVUS) plans to announce the results from a phase 2 study evaluating the safety and efficacy of Qnexa, for the treatment of obstructive sleep apnea (OSA), on January 7th prior to market open. The announcement will be followed by a webcast and conference call at 8:30 a.m. Eastern time.

Conference Call Information

Domestic callers: 1- 888-806-6202

International callers: 1- 913-312-6680

Webcast information: http://ir.vivus.com. A webcast replay will be available on the VIVUS web site for 30 days.

About the Sleep Apnea (OB-204) Study

The phase 2 study (OB-204) was a single-center, randomized, double-blind, placebo-controlled parallel group trial including obese men and women (BMI 30 to 40 kg/m2 inclusive), 30 to 65 years of age with OSA (apnea/hypopnea index greater than or equal to 15) at baseline, who had not been treated with, or who were not compliant with continuous airway pressure (CPAP) devices within three months of screening. Patients were randomized to placebo or full-dose Qnexa. Patients underwent a four-week dose titration followed by 24 weeks of additional treatment. All patients were also provided with a lifestyle modification program focusing on diet and exercise. Overnight polysomnography was performed at baseline, Week 8 and Week 28. The primary endpoint was the change in Apnea/Hypopnea Index (AHI) between baseline and Week 28; secondary endpoints included weight loss, oxygen saturation and changes in blood pressure.

About Obstructive Sleep Apnea (OSA)

Obstructive sleep apnea (OSA) is a sleep-related breathing disorder that involves a decrease or complete halt in airflow despite an ongoing effort to breathe. Approximately 18 million Americans are living with OSA, though an estimated 90 percent of patients remain undiagnosed or untreated. Studies have identified a relationship between OSA and a number of cardiovascular and metabolic diseases including hypertension, diabetes, stroke, congestive heart failure and sudden cardiac death. Currently, there are no pharmacotherapy agents approved to treat sleep apnea. More information on sleep apnea can be found on the American Academy of Sleep Medicine website at: http://www.aasmnet.org/Resources/FactSheets/SleepApnea.pdf

Source: VIVUS

 

Leader in Opiate and Ambien Detoxification Shares Insight into the Effects of Ambien Misuse and Withdrawal

The Waismann Method, a pioneering medical opiate detoxification procedure, offers one of the most advanced medical procedures worldwide with the medical expertise and advanced technology to treat dependencies to Zolpidem, a prescription medication widely used for the short-term treatment of insomnia and prescribed under trade names including Ambien and Edluar. The Waismann Method of Rapid Ambien Detox involves a safe, medically-assisted treatment to Ambien addiction in a hospital setting. This approach offers patients an alternative to traditional Ambien detoxification, which even when done gradually, can be extremely dangerous and even life threatening.

"Sleep problems are common in today's society. Ambien and other prescription sleep aids can help insomnia, but should only be taken as an interim resolution," said Dr. Michael Lowenstein, co-director for the Waismann Method. "When Ambien is taken for an extended period of time or in high doses, users can develop a tolerance to the drug, making it habit forming. Misuse of Ambien can potentially lead to short-term memory loss as well as bizarre side effects such as binge eating or sleepwalking."

Ambien, the brand name of Zolpidem, is a non-narcotic sleep aid meant for short-term treatment. It is considered a Schedule IV Controlled Substance in the U.S. and is a central nervous system depressant which slows normal brain activity. The sedative is also considered a hypnotic with effects similar to drugs in the benzodiazepine family such as Xanax, though they are molecularly different. Ambien can impair thinking and reaction time so users should avoid tasks that require alertness, such as driving or operating machinery.

According to Lowenstein, if a user develops a tolerance to Ambien and attempts to abruptly discontinue use, serious withdrawal symptoms can arise including insomnia, fatigue, panic attacks, stomach cramps, muscle cramps, sweating, shaking and seizures. Gradually decreasing daily intake is the best way to wean from Ambien, but many people need medically-supervised treatment. "Trying to detox on your own can be dangerous and should be supervised in a medical setting where withdrawal can be managed," Lowenstein adds.

Medically assisted withdrawal using Rapid Ambien Detox enables individuals to safely and comfortably reverse their dependence without difficult and prolonged withdrawal. The Waismann Method of Rapid Ambien Detox takes approximately seven to ten days, as opposed to traditional detoxification methods that require 30 to 90 days or more, and can be administered alone or concurrently with deep sedation detoxification from opiates.

Patients in the Waismann program are supervised closely in a hospital setting to maximize success and safety. All Waismann Method physicians are Board Certified in Anesthesiology, Pain Management, and Addiction Medicine. Treatment is tailored to the unique medical needs of each individual patient.

To learn more about Rapid Ambien Detox or the Waismann Method call 1-800-423-2482 or visit www.opiates.com.

About The Waismann Method:  Performed in a hospital, the Waismann Method involves the administration of medications to reverse the physiological dependence on opiates or Zolpidem while the symptoms of withdrawal are addressed. During the procedure, the patient experiences minimal withdrawal, and will be able to return home within days. Seventy-five percent of the prescription drug dependent patients who are treated with the Waismann Method remain drug free after one year.

SOURCE Waismann Method

Apnex Medical, Inc., a private medical device company, announced that it has completed a second round of private equity financing totaling $14 million. The funds will be used to complete a clinical study and develop a second generation of its proprietary implantable technology designed to treat obstructive sleep apnea (OSA).

Participants in the financing include Domain Associates, New Enterprise Associates (NEA), Polaris Venture Partners and Michael Berman. The current board includes Robert Atkinson, CEO, and Michael Berman, Chairman, together with Brian Chee, John Nehra and Nimesh Shah representing Polaris, NEA and Domain, respectively. This financing brings the total investment in Apnex Medical to $30 million.

"We are very excited about the early results with the Apnex Hypoglossal Nerve Stimulation (HGNS(TM)) System in our clinical study. Our technology really has the potential to change the lives of people suffering from OSA. This round of financing will allow us to finish our initial clinical study and get us that much closer to market," said Robert Atkinson, CEO.

"From prior research published by Drs. Alan Schwartz and Philip Smith, we know that hypoglossal nerve stimulation has the potential to reduce OSA severity. The clinical study of the Apnex HGNS System should provide evidence of its safety and effectiveness over time," said Mr. Atkinson. Drs. Schwartz and Smith, both Professors of Medicine at Johns Hopkins University School of Medicine, are among the early pioneers in this field and serve as consultants to Apnex Medical.

About Obstructive Sleep Apnea (OSA):

"OSA is a very serious health condition, and if left untreated, it can lead to major health problems. Currently the majority of sleep apnea remains undiagnosed and among those who are diagnosed, many are either untreated or only partially treated. Thus, many of us are supportive of research into new forms of therapy," said Atul Malhotra, Medical Director of the Brigham and Women's Sleep Disorders Research Program and an Associate Professor at Harvard Medical School in Boston. Dr. Malhotra performs research into the mechanisms underlying sleep apnea and serves as a consultant to Apnex Medical. Malhotra further stated, "If you think you have a sleep problem, you should talk to your doctor or consider seeing a specialist."

According to the World Health Organization, approximately 100 million people worldwide are suspected to have OSA. In the United States, symptomatic OSA affects 1 in 4 men and 1 in 9 women. OSA causes fragmented sleep and excessive daytime sleepiness, resulting in an increased risk in accidents and lost productivity. Untreated OSA is also associated with an increased risk in stroke, high blood pressure, coronary artery disease, heart failure and type 2 diabetes. Recent studies have also confirmed that untreated OSA is associated with an increased risk of death. Current OSA treatments are not always successful or well tolerated. The Apnex HGNS System is designed to provide an alternative treatment for OSA that addresses these problems.

SOURCE Apnex Medical, Inc.

The American Trucking Associations (ATA) will co-sponsor the first-ever national conference on sleep apnea and commercial motor vehicle drivers on May 12, 2010.

Obstructed sleep apnea (OSA) is a condition in which an individual's airway is blocked while sleeping, typically resulting in frequent breathing interruptions lasting from 10 seconds to more than a minute at a time, loud snoring and non-restorative sleep. The illness afflicts at least 20 million Americans -- equal to or more than asthma or diabetes -- yet more than 85 percent remain undiagnosed. Individuals with OSA are more likely to have high blood pressure, heart problems, stroke and depression, contributing to annual health care costs that are twice that of people without sleep apnea.

"It is important that the trucking industry actively engages in improving the quality of life and the performance of our drivers," said ATA President and CEO Bill Graves. "Professional truck drivers play a vital role in delivering our nation's freight."

The conference, hosted by the American Sleep Apnea Association (ASAA), will feature presentations and panel discussions that focus on providing a common understanding of OSA diagnosis and treatment, clarifying current and proposed regulations, establishing an ongoing forum of experts to generate guidance for improvements, and providing trucking management with the resources to improve employee health and safety.

"The trucking industry continues to grapple with the tough questions and issues surrounding screening and treatment for sleep apnea," said Dave Osiecki, ATA Vice President of Safety, Security and Operations. "This event is a significant step forward and we encourage industry stakeholders to participate."

The one-day conference will be held at the Westin Baltimore Washington - BWI in Baltimore, Md. and is preceded by a reception and keynote address from National Transportation Safety Board Chairman Deborah Hersman on May 11, 2010.

For more information, visit the ASAA conference Web site at www.satc2010.org.

The American Trucking Associations is the largest national trade association for the trucking industry. Through a federation of other trucking groups, industry-related conferences, and its 50 affiliated state trucking associations, ATA represents more than 37,000 members covering every type of motor carrier in the United States.

SOURCE American Trucking Associations

Sleep HealthCenters, a leading provider of sleep medicine services in the US, is proud to announce the formation of SleepPartners (www.sleeppartners.com) - a nationwide network of exceptional accredited sleep centers with board-certified sleep specialists and a focus on superior sleep disorder care.

The expertise of these sleep programs combined with their geographic reach extends high quality sleep medicine services throughout the country under one network. Each SleepPartners member shares a common vision of the value of sleep as it relates to overall health and wellness. Beyond local sleep medicine centers, the network offers services on a national basis, such as corporate wellness and payer disease management programs.

A recent example is the latest recommendation of the National Transportation Safety Board that all transportation providers test their employees for sleep apnea. The SleepPartners network is in an optimal position to design and implement customized sleep testing programs for these national organizations.

"Corporate Wellness Programs educate employees on the importance of sleep, screen employees for sleep disorders, diagnose those screened as high-risk and then provide treatment options and follow-up care. The SleepPartners network members provide the flexibility and responsiveness critical to offering these services nationally," said Paul Valentine, CEO of Sleep HealthCenters.

Each SleepPartners center reflects a consistent level of quality, evidenced by accreditation through the American Academy of Sleep Medicine or The Joint Commission, board-certified sleep specialists, and the ability to provide a comprehensive sleep medicine program including evaluation, diagnostics, treatment and long-term management for all sleep disorders.

"The SleepPartners network allows our centers to be connected to other sleep centers in the country who share a unified approach to sleep medicine," states Joseph M. Ojile, MD, Medical Director of the Clayton Sleep Institute in St. Louis. "This ensures consistent care and a high level of quality is maintained, whether a patient or employer is in Boston, St. Louis, or Phoenix."

The SleepPartners network currently includes close to 100 centers across the United States and is increasing to offer sleep medicine services in every major region in the United States.

SOURCE Sleep HealthCenters

Reportlinker.com announces that a new market research report is available in its catalogue.

Central Nervous System Insomnia or Sleep Disorders

Life Science Analytics', Central Nervous System Insomnia or Sleep Disorders contains detailed information on the current drug pipeline. This report provides insight into the pipeline status of insomnia or sleep disorders drugs by company and by stage as well as a summary of the latest news and developments in this area.

Scope of the report:

Each Life Science Analytics' Therapy Area Pipeline Report provides the user with real detail on drug pipelines, by company and by stage, for each specific therapy area. The latest news, by company, also ensures that each report is fresh and up-to-date.

In addition to new developments and disease specific pipeline projects, each report also contains extensive information in tabular format on a company's full product pipeline and products by phase of development with regard to the therapy area.

Full pipeline details, by stage, are provided and include detailed product descriptions, information on partnering activity plus clinical trial intelligence. Each Therapy Area Pipeline Report also provides detail on the top 20 companies with products in the early stage of development and the top 20 companies with products in the late stage of development. Finally, each report also provides a comparison with other major indications in the disease hub based on Marketed Products vs. Pipeline Products.

Key benefits

-- Understand a company's strategic position by accessing detailed independent intelligence on its product pipeline for specific therapy areas.

-- Keep track of your competitors and partners by better understanding their product pipeline.

-- Monitor a company's research effectiveness by determining pipeline depth and number of products in development by clinical phase for specific disease areas.

-- Maintain a critical competitive advantage.

Epidemiology Report

% of Products by Phase of Development

No. of Products by Phase of Development

Marketed Products vs. Pipeline Products

Company Overview - Pipeline Projects

--Top 5 Companies in Early Stage Insomnia or Sleep Disorders Products

--Top 5 Companies in Late Stage Insomnia or Sleep Disorders Products

--Top 5 Companies in Marketed Insomnia or Sleep Disorders Products

Patent Expirations

Upcoming Milestones

Product Sales

Full Pipeline View

--Product Details : Unknown/Research

--Product Details : Pre Clinical

--Product Details : Phase I

--Product Details : Phase II

--Product Details : Phase III

--Product Details : Pending Approval

--Product Details : Approved

--Product Details : On the Market

--Product Details : Post Marketing

News Updates

--Intellectual Property

--Product Updates

--Regulatory

To order this report:

Central Nervous System Insomnia or Sleep Disorders

http://www.reportlinker.com/p0161866/Central-Nervous-System-Insomnia-or-Sleep-Disorders.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=prnewswire

SOURCE Reportlinker

When clocks go back an hour early Sunday morning, our roads and highways may become more dangerous as people drive drowsy, according to The National Road Safety Foundation, Inc. (NRSF), a non-profit group that offers free driver safety programs.

Drowsy driving is a significant factor in traffic crashes. The risk increases as daylight savings time ends and we spend more time driving at night, says David Reich of NRSF. "Drowsy driving is as dangerous as drunk driving," he notes.

Studies show 60 percent of U.S. motorists have driven while fatigued and nearly 37 percent admit to having fallen asleep at the wheel.

Drowsy driving is especially prevalent among teens, who tend to keep late hours and think they can function on minimal sleep. Teens actually require more sleep than adults.

NRSF urges drivers to be alert to signs of drowsiness while driving:

• Difficulty focusing, frequent blinking, rubbing eyes
• Daydreaming or not remembering the last few miles driven
• Head snaps, yawning
• Drifting out of your lane, tailgating or hitting rumble strips
  

If you experience any of these warning signs, pull over safely and take a break. Have a cup of coffee or a caffeinated snack or take a 20-minute nap. Allow 30 minutes for caffeine to enter your bloodstream. Never drink alcohol before driving and know if any medications you take might induce drowsiness.

The National Road Safety Foundation, with National Organizations for Youth Safety, is sponsoring a competition for young people ages 13 - 22, inviting ideas for public service announcements that address drowsy driving or other safety issues including speeding, seat belt usage, and driving while drunk or distracted. The winner will receive $1,000 and a trip to New York to see the idea professionally produced into a public service announcement that will air on TV nationwide. Entry deadline is Nov. 21. Information is at www.drivetolife.com.

For more than 45 years, the National Road Safety Foundation has produced films and teaching materials that have been used to train millions of young drivers about the dangers of drinking and driving, speeding and aggressive driving. To download or receive a free copy of the Foundation's program on drowsy driving, "Almost Home," and other free driver education programs, visit the NRSF website at www.nrsf.org.

To see press release go to http://myprgenie.com/2862

Contact: David Reich, david@nrsf.org, 212 573-6000

SOURCE The National Road Safety Foundation

Transcept Pharmaceuticals (Nasdaq: TSPT) announced today 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.

The FDA requested additional data demonstrating that Intermezzo®, when taken as directed in the middle of the night, would not present an unacceptable risk of residual effects, with particular reference to next day driving ability.

The FDA also expressed two concerns regarding the possibility of patient dosing errors in the middle of the night that could lead to next day residual effects. Specifically, the FDA has asked Transcept to address methods to avoid inadvertent dosing with less than four hours of bedtime remaining, and inadvertent re-dosing in a single night.

Based upon the content of the letter, it is possible that Transcept will need to conduct one or more additional safety studies. Transcept will request a meeting with the FDA to discuss specific requirements for approval.

Glenn A. Oclassen, President and Chief Executive Officer of Transcept, commented, "Transcept is committed to making this important new potential therapy available to insomnia patients. We will continue to work closely with the FDA to address their questions and define the path forward for Intermezzo®."

Conference Call Scheduled

Transcept will host a conference call and live webcast to discuss the Complete Response Letter on Thursday, October 29, 2009, at 8:30 a.m. EDT. Telephone numbers for the live conference call are 866-206-7202 (U.S.) or 703-639-1112 (International). The webcast can be accessed on the Investors page of the Transcept website at www.transcept.com and will be available for replay until close of business on November 12, 2009. A playback of the call will be available through November 12, 2009 through a telephone replay number that can be obtained through Transcept at 510-215-3500.

About Intermezzo®

Intermezzo® (zolpidem tartrate sublingual tablet), the lead product candidate at Transcept, 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® is a sublingual low dose formulation of zolpidem, the active agent most commonly prescribed in the United States for the treatment of insomnia. Intermezzo® 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.

Two Phase 3 clinical studies evaluated 376 patients receiving either Intermezzo® or placebo. In the first study, a sleep laboratory trial using an objective polysomnographic endpoint, Intermezzo® demonstrated a statistically significant decrease versus placebo in the time it took patients to return to sleep as measured by Latency to Persistent Sleep. In the second study, an outpatient trial, Intermezzo® demonstrated a statistically significant decrease in Latency to Sleep Onset, a subjective patient reported endpoint. The most common adverse event seen in these trials was headache (2.7 percent active versus 1.4 percent placebo in the outpatient study).

Transcept is actively pursuing patents to protect Intermezzo® 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®.

SOURCE Transcept Pharmaceuticals, Inc.

On today's Dr. Oz Show the topic was fatigue, including its most debilitating manifestation, Chronic Fatigue Syndrome (CFS).

Dr. Oz's guest Jacob Teitelbaum, MD, best-selling author of From Fatigued to Fantastic! (Avery Penguin Group) and Pain Free 1-2-3 (McGraw-Hill), suffered from CFS when he was in medical school and had to drop out for a year to recover. The disease left him homeless and sleeping on park benches, but this defining experience ignited a passion to learn everything he could about the disease and beat it.

"From that time, my medical career has been focused on finding effective treatment for CFS and its painful cousin fibromyalgia, which together afflict at least 12 million Americans," explained Dr. Teitelbaum, who serves as medical director of the national Fibromyalgia and Fatigue Centers www.fibroandfatigue.com. His landmark study on Chronic Fatigue Syndrome (Journal of Chronic Fatigue Syndrome, 8:2, 2001) showed that 91 percent of patients using his SHINE treatment protocol improved, with an average improvement in quality of life of 90 percent.

"SHINE stands for Sleep, Hormones, Infections, Nutrition and Exercise--the critical areas we focus on treating to help CFS patients get their lives back," said Dr. Teitelbaum. "Our free online symptom analysis program helps to streamline the process, customizing treatments that you and your physician can easily incorporate."

Although many stresses, including numerous infections, can trigger CFS, Dr. Teitelbaum identifies hypothalamic dysfunction as the mechanism responsible for the wide range of disabling and seemingly unconnected symptoms suffered by CFS patients. "If you're exhausted but can't sleep, experience brain fog, weight gain, achiness, and low libido--it's highly likely that you have Chronic Fatigue Syndrome," he explained. "When the system is over-stressed, the hypothalamus acts like a circuit breaker that shuts off the power to protect body and mind from further damage.

"I know what patients are going through," Dr. Teitelbaum concluded. "Regardless of what doctors may have told you in the past, this disease is real, but it is treatable and you can get your life back."

For more information, visit http://www.endfatigue.com. Also see Dr. Teitelbaum's blog entries on Dr. Oz's website at http://www.doctoroz.com/expert/jacob-teitelbaum-md.

SOURCE Dr. Teitelbaum

In preparation for its Winter of 2009 opening, True REST Float Center has launched its new website, http://Truerest.com. The center is the first in the United States to offer REST pod technology.

The website walks potential clients through every step of the float experience. In addition to a video overview, site features include:

• An online reservation system
• Members' area
• Special discounts
• Live help
• Complimentary products and services
  

Flotation REST (Restricted Environmental Stimulus Therapy) involves floating on top of a pool of saltwater - 10 inches of purified water and 800 pounds of specifically formulated Epsom salt imported from Germany. Because of the high salt content of the water, which is heated to skin surface temperature, a person is able to float effortlessly. According to the website's video, the "special solution of salinated water makes floating on water feel like floating on air."

Owner Nick Janicki said Flotation REST - originally developed in the '70s - is an idea whose time has come. Recent studies have linked lack of sleep to problems ranging from obesity, memory loss, and a weakened immune system. True REST owner Nick Janicki said the REST pod is designed to take flotation into the 21st century. "Lack of sleep is approaching epidemic proportions," said Janicki. "We believe 60 minutes in our technology will surpass the benefits gained from the most restful sleep."

Flotation REST also has been associated with the following benefits:

• Eliminates jet lag
• Alleviates stress
• Energizes, rejuvenates and revitalizes
• Quickens rehabilitation and recovery
• Relieves pain
• Boosts immunity
• Improves circulation
• Reduces blood pressure, pulse, heart rate and oxygen consumption
• Sharpens mental clarity and alertness
  

The 60-minute float sessions include a wide variety of musical choices and guided audio. Audio guidance can help clients experience enhanced mental, physical, and emotional states. Specific sound frequencies can help clients tap into more of the brain's innate abilities, enter deep meditative states reliably and easily, reduce stress, enhance creativity and become more productive.

    Membership packages are available as follows:

    Basic: $59 (one float per month)
    Plus: $99 (two floats per month)
    Premium: $180 (four floats per month)

Many additional services and benefits are provided to members free of charge, including an oxygen bar, quiet room and loyalty points.

"With medical factors pointing to the importance of rest, Flotation REST sessions are not a luxury but a necessity for a healthy lifestyle," said Janicki. "I invite anyone interested to visit http://Truerest.com for more information - and, in November, to visit our facility and experience it for themselves."

SOURCE True REST Float Center