Cephalon today announced the U.S. Food and Drug Administration (FDA) has granted a priority review for its supplemental New Drug Application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV], which was filed in June of this year. The FDA decision on approval of NUVIGIL as a treatment for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel is expected by December 29, 2009. There currently is no FDA-approved treatment for jet lag disorder.

The NUVIGIL sNDA is based on data from a Phase III pivotal study that evaluated the efficacy and safety of NUVIGIL (50 or 150 mg/day) in 427 healthy adults over three days during travel from the United States to Europe. These data were presented earlier this year at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies.

Specifically, the FDA is reviewing Nuvigil as a treatment for “improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel,” Cephalon said.

With priority review status, the FDA will make its decision on whether to approve the drug within six months, rather than the usual 10- to 12-month review period. The agency grants priority review to products that are considered to be potentially significant therapeutic advancements over existing therapies.

Your eyelids droop and your head starts to nod. Yawning becomes almost constant and your vision seems blurry. You blink hard, focus your eyes and suddenly realize that you’ve veered onto the shoulder or into oncoming traffic for a moment and quickly straighten the wheel. This time you were lucky; next time you could become the latest victim of the tragedy of dowsy driving.

Listen to this shift described in his email:

- He got called into work on Sunday at 4 AM
- He did a total of 10 runs over the next day and a half
- He returned home on Monday at 11:30 PM

He mentioned that he had a couple of ‘cat naps’ – none lasting any longer than 45 minutes.

If you drive for a living, you need to be aware of the effects that Shift Work can have on your driving.

According to the National Sleep Foundation’s Sleep in America poll, 60% of Americans have driven while feeling sleepy and 37% admit to actually having fallen asleep at the wheel in the past year. However, many people cannot tell if or when they are about to fall asleep. And if sleepiness comes on while driving, many say to themselves, “I can handle this, I’ll be fine.” Yet they’re putting themselves and others in danger. What they really need is a nap or a good night’s sleep.

Here are some signs that should tell a driver to stop and rest:

Difficulty focusing, frequent blinking, or heavy eyelids
Daydreaming; wandering/disconnected thoughts
Trouble remembering the last few miles driven; missing exits or traffic signs
Yawning repeatedly or rubbing your eyes
Trouble keeping your head up
Drifting from your lane, tailgating, or hitting a shoulder rumble strip
Feeling restless and irritable

Not Westbound. Eastbound, the company says. How would they know Eastbound and not Westbound?

Turns out Cephalon put 427 adults through what has to be the best clinical trial ever: They flew them from the East Coast of the U.S. to France for a vacation observation.

Subjects were flown from the East Coast of the United States through six hours of time zone changes to arrive in France early in the morning, where they were escorted to a sleep center. Subjects were then given NUVIGIL or placebo once a day for three days. … Patients taking 150-milligram dose of NUVIGIL showed a statistically significant improvement over placebo.

But besides taking Nuvigil (or Viagra as some have reported), what else can you do?

Katherine Huether has put together her Top 5 which are simple, easy to do and don’t require a prescription:

1. Take Melatonin
Melatonin is the hormone responsible for regulating sleep cycles. Supplementing it can help you fall asleep at normal hours when you are at your new location. Just take the melatonin thirty minutes to an hour before your desired bed time. I’ve used this remedy before and it seems to help reset my body clock within a day or two.

2. Daylight Hours
One of the easiest and most effective methods I’ve used to beat jet lag is to observe regular daylight hours. Even if you don’t feel tired, force yourself to go to sleep and wake up during your regular hours. It also helps to resist the urge to nap. For example, if you arrive at a destination in the early morning, it is best to try to stay awake until your normal bedtime. If you can’t make it that long, try to get close.

3. Stay Hydrated
Water can really help control jet lag. Being at a high elevation for extended periods of time and in the dry airplane cabin can really sap your body of moisture. Dehydration can really affect your body’s ability to adapt to the new time zones. In order to help with jet lag I make sure to drink enough water before, during, and after the flight. I do notice that it helps me maintain my energy once I arrive at my destination.

4. Drink Green Tea
Green tea can help promote sleep and control stress and anxiety. If your jet lag is preventing you from relaxing when it’s time for bed, drinking decaf green tea can help considerably. I drink a few cups of green tea a day, especially when I am experiencing jet lag.

5. Try Valerian
Valerian is another herb that helps me get to sleep and can be very useful with jet lag. I usually take about 15-20 drops of the tincture mixed in with a little water thirty minutes before bedtime. What I like about this herb is that I wake up feeling well rested and refreshed.

Prescribed for the treatment of narcolepsy, shift work sleep disorder (SWSD), and daytime sleepiness associated with sleep apnea, Nuvigil is chemically similar to Provigil, but Cephalon says its effects are longer-lasting than Provigil based on concentrations in plasma.

To encourage people to switch to Nuvigil:

1. Nuvigil is available at an 11% discount compared to Provigil.

2. An innovative prescription savings program for Nuvigil.

Under the program, Cephalon will pay for up to $50 in monthly out-of-pocket costs for Nuvigil, bringing the cost down to a floor of $10. For many patients, with an average co-pay of roughly $40, this will lower monthly copays to $10.

From the Nuvigil website:

If you and your doctor decide that NUVIGIL is right for you, this eVoucherRx Program could help you save up to $50.00 off each of your next twelve (12) prescriptions, depending on your out-of-pocket costs. Please see additional terms and conditions below. eVoucher Rx is a trademark of RelayHealth and/or its affiliates.

Click here for a list of preferred pharmacies. Other pharmacies: if you fill your prescription at CVS, Walgreens, some independent pharmacies, or another nonparticipating pharmacy, you can present a NUVIGIL Prescription Savings Program Card to your pharmacist along with your eligible prescription for NUVIGIL to receive up to $50 off your co-pay.

Cephalon is also offering a FREE 7-day Starter Coupon.

Here are the terms for the free coupon:

Coupon is good through 7/31/2011. Valid only in the United States. No purchase required. Void in Massachusetts and where prohibited by law. Not valid for any individual for whom any part of any prescriptions for NUVIGIL is or will be covered by Medicaid, Medicare (including Medicare Advantage or Part D Prescription Plans), or any other public payor program. Product dispensed pursuant to terms of coupon shall not be submitted to any third-party payor, public or private, for reimbursement. Offer is valid one time only per patient and must be submitted pursuant to an original coupon. It is illegal for any person to sell, purchase, or trade; or to offer to sell, purchase, or trade or to counterfeit this coupon. Offer cannot be combined with any other certificate, coupon, rebate, or similar offer. This is not an insurance program. Cephalon reserves the right to rescind, revoke, or amend this program without notice.

Provigil will face generic competition in the United States beginning in 2012 – so for the next 2 years, if you are a Provigil user, Nuvigil may be your best economic solution.

“Medical workers experience tremendous stress on the job which can lead to fatigue and sleep impairment,” reports Betsy Connolly, Working Nights` President. “Our calendar provides workers with meaningful tips about health and safety and an opportunity to better manage their lives when working shifts.”

The topics highlighted in the calendar all focus on related health and safety education and prevention for medical workers. February`s topic is Reducing Ergonomic Risks. According to a recent report by the Bureau of Labor Statistics, 2.5% of nursing aides, orderlies, and attendants experienced Musculoskeletal Disorders (MSDs) – injuries or illnesses that affect the connective tissues of the body such as muscles, nerves, joints, tendons, cartilage, or spinal discs.

This rate is more than seven times the average national rate of MSDs for all occupations. According to the report, almost 30 percent of all days away from work were related to MSDs. Preventing MSDs requires work scheduling that reduces the time of exposure to demanding work conditions and promotes healthful work-rest patterns.

With the increased use of on-line shift scheduling by health care employees, workers need to make sure that the shift schedules they sign up for maximize sleep opportunities to prevent fatigue related errors, provide adequate recovery periods to limit personal injury risk, and provide time for social activities with friends and family members. Other calendar topics include, Men and Women and Sleep, Managing Hazardous and Toxic Substances, Lowering Stress and Anxiety, New Tips about Caffeine, Restless Leg Syndrome and Vitamin Tips. The calendar incorporates color-coded stickers to help workers and their families manage their day-to-day lives.

Employers can customize the calendar with their organization`s logo and include
specific messages to employees. The 2010 Working Nights Creative Arts Calendar
Contest is also available to health care employers. The Contest offers
organizations the opportunity to create a custom health and safety calendar
incorporating winning illustrations or photographs submitted by the
organization`s employees and their family members. Winners` artwork and their
names will be included in the calendar.

To learn more about Working Nights, please visit http://www.workingnights.com/
or http://www.workingnights.com/blog/.

Cephalon founder Frank Baldino, Jr., Ph.D., has led the company from a privately held start-up to one the top ten biotechnology companies in the world.

Today, just two decades after its founding, Cephalon has eight products in the United States in the areas of central nervous system disorders, cancer, and pain; and more than 30 products in 50 countries worldwide. In 2007, Cephalon first joined the list of the Fortune 1000 annual ranking of America’s largest corporations.

Dr. Baldino received his Ph.D. in pharmacology from Temple University. From 1981-1987, he served as senior research biologist in the medical products department at E.I. duPont de Nemours & Company, where he was responsible for developing research strategies for identifying novel neuropharmaceutical agents. He has authored more than 100 publications in peer-reviewed journals such as Nature, Journal of Neuroscience Research, and Brain Research.

Over the course of his career, Dr. Baldino has received numerous awards and broad recognition for professional achievements. Most recently in 2007, he was named one of the “100 Most Inspiring People” by PharmaVOICE, and included in a list of entrepreneurs who are redefining the life-sciences industry through innovative approaches to improving technologies, processes, services and ultimately patient care. Dr. Baldino received the first Hubert J.P. Schoemaker Leadership Award, which recognizes a leader in the biosciences community who best exemplifies the spirit of innovation in the Commonwealth of Pennsylvania.

He chairs the Executive Council of the Harvard Division of Sleep Medicine and is a member of the Board of Trustees at Temple University, the University of the Sciences in Philadelphia, and The Franklin (formerly known as The Franklin Institute). In addition, Dr. Baldino serves as a member of the Board of Directors for the Greater Philadelphia Chamber of Commerce, the Eastern Technology Council, BioAdvance Biotechnology Greenhouse Corp., Quaker BioVentures, L.P., Valeritas, Inc., Viropharma Incorporated, and Pennsylvania BIO. He is also a member of the Board of Directors for NicOx, S.A., and Acusphere, Inc.

Dr. Baldino is a member of the Healthcap Advisors Board and the MPM Capital and Vantage Point Venture Partners Advisory Committee. He also holds several adjunct academic appointments and serves on the Muhlenberg College Board of Observers.

Baldino was presented with the award at the chamber’s annual dinner this week.

The Dangers of Drowsy Driving – Matthew Betz’s second presentation will discuss the scope of drowsy driving; how to identify drowsy driving crashes in your fleet; if your fleet drivers are at risk; and how to reduce the risk of drowsy driving crashes in your fleet.

According to the AAA Foundation people at work who sleep only six hours and work more than 60 hours per week have an increased risk for drowsy driving which is almost four times greater than the general population. And falling asleep at the wheel can be just as dangerous as drinking and driving. Drowsiness can produce the same types of effects as alcohol: impaired vision, slower reaction time, impaired judgment, decreased awareness and handeye coordination, all of which increase the chances of having an accident. Studies have shown that people who have been awake for 18 hours show a blood alcohol concentration (BAC) of 0.05, and those awake for 20 hours have a 0.08 BAC level, which is legally drunk in many states.

And night drivers are at the most risk.

The National Institute for Occupational Safety and Health states that traffic-related motor vehicle crashes are the leading cause of work-related deaths, and data shows that there is a greater increase during the night shift. There is also the problem associated with driver fatigue common among shift workers. For many, shift work results in sleep deprivation, which can be risky when employees are behind the wheel.

The conference, presented by the Alabama Chapter of NAFA Fleet Management Association, kicks off with a pool side reception sponsored by NAPA Auto Parts on Thursday night and followed by two days of presentations and networking on Friday and Saturday. NAFA is the association for the diverse vehicle fleet management profession regardless of organizational type, geographic locationor fleet composition. NAFA’s Full and Associate Members are responsible for the specification, acquisition, maintenance and repair, fueling, risk management, and remarketing of more than 3.5 million vehicles including in excess of 1.1 million trucks of which350 thousand are medium- and heavy-duty trucks. For more information visit http://www.nafa.org

Shift work disorder is a common Circadian rhythm sleep disorder and would probably be experienced by Astronauts visiting Mars.

In this study, seven healthy young men lived in a personal laboratory room free of time cues for 73 days. Prior to the study, the men maintained a regular 8-hour sleep/16-hour wake schedule for three weeks at home, and did not take medications and/or drugs the week before or during the study.

During the study, ambient light and room temperature were controlled and sleep opportunities were scheduled. Subjects lived on the Martian day and the 23.5-hour day, alternately for two-week intervals. During this time, Scheer and colleagues tested whether the experimental light conditions could synchronize the biological clock of the subjects to the non-24-hour sleep/wake cycles.

Following each two-week session, the researchers tested whether an individual’s circadian period showed longer-term changes that outlived the light/dark cycles – whether the period was lengthened or shortened – by measuring the intrinsic period of rhythms of core body temperature and the hormones melatonin and cortisol.

The researchers found that exposure to moderately bright light for the second or first half of the scheduled wake period was effective for entraining individuals’ biological clocks to the 24.65-hour Martian day or to the 23.5-hour day, respectively.

According to the U.S. Army Safety Center, approximately 9 percent of the wheeled-vehicle crashes that resulted in injury or death during Operation Desert Shield and Operation Desert Storm were attributed to driver drowsiness/fatigue.4

Much Bigger Problem Than Imagined
The National Highway Traffic Safety Administration estimates that from 1989 through 1993, driver drowsiness/fatigue was a contributing factor in 100,000 crashes annually on U.S. highways.2 During the same five-year period, drowsiness/fatigue was cited as a factor in an annual average of 1,357 fatal crashes (3.6 percent of all fatal crashes). As a result, about 1,544 people were killed each year.3 These statistics for driver sleepiness and accidents are considered conservative because of differences in state reporting practices, lack of firm evidence about the cause of many crashes, and failure of drivers involved in crashes to report that sleepiness played a role.

The Federal Highway Administration’s (FHWA) Office of Motor Carriers (OMC) has made driver drowsiness/fatigue the dominant human factors research issue in its research and technology (R&T) program. OMC has more than 25 completed, ongoing, or planned R&T projects related to driver drowsiness/fatigue and hours-of-service regulations.

Driver fatigue is a safety issue of special concern to the commercial motor vehicle (CMV) transportation community. CMV drivers may drive up to 10 hours continuously before taking a break, often drive at night, and sometimes have irregular and unpredictable work schedules. Much of their mileage is accumulated during long trips on interstate and other four-lane roadways. Because of their extensive mileage exposure and other factors, commercial drivers’ risk of being involved in a fatigue-related crash is far greater than that of non-commercial drivers C even though CMV drivers represent only about 4 percent of the drivers involved in known fatigue-related crashes and rate of involvement per mile traveled is no greater than that of non-commercial drivers.

With the downturn in the economy and more Americans taking 2nd and 3rd jobs – many are wondering … is the up tick in Drowsy Driving from general fatigue?

Only time will tell but we do know this …

Until people can stay away while driving, more and more accidents will continue to occur.

Pilots should be screened for sleep disorders during medical certification.
More research should be conducted on fatigue in short-haul flight operations.
Any information from research on fatigue should be made available to flight crews working short-haul flights.
Guidance from research should be included in operators’ operating specifications.
The FAA should implement a program to identify pilots at high risk for sleep apnea.
Guidance should be made available for pilots, employers and physicians regarding the identification and treatment of individuals at high risk of sleep apnea.