Cephalon, Provigil, and Nuvigil have had a hard week so far and it’s only Tuesday. First, no relief from antitrust lawsuits and now a painful denial from the Food and Drug Administration (FDA). Thus are the ongoing trials and tribulations of defective drugs.
Cephalon is a rising star in the pharmaceutical industry clearing a cool $1 billion in profit last year with their “wonder drug” Provigil and their longer lasting (thus making it more wonderous) drug Nuvigil. Both drugs are approved to treat the excessive sleepiness associated with narcolepsy, sleep apnea and shift work.
What’s really miraculous about Cephalon’s drugs is that they have gotten a tremendous amount of free positive publicity thanks to President Obama, who was allegedly prescribed the drug because he is only allowed to sleep one hour per month. With that type of endorsement who wouldn’t take it?
This is on top of the thousands of college students that have somehow gotten their hands onto it to help them through grueling finals and mid terms. Then there are the Youtube videos of people partying the night away on a Tuesday, just to wake up after an hour of sleep, pop a Provigil, and go on their merry way to be productive at work filing things or driving a school bus or whatever.
No wonder Cephalon is chomping at the bit to get its new drug Nuvigil approved for new “ailments” that are not part of the original intent of the drug. They wanted the Food and Drug Administration to approve it as the first drug to fight the growing epidemic of jet lag. If approved, the drug might as well be stocked on the shelves.
You see, Provigil is expected to face generic competition in 2012, so Cephalon is trying to shift as many patients as possible to Nuvigil, which has a longer patent life. Getting Nuvigil, but not Provigil, approved to treat jet lag was one element of that strategy.
Yet the widespread distribution of the drug could also expose the larger public to the very crippling and sometimes fatal side effects associated with Provigil and Nuvigil.
What Do Provigil and Nuvigil Do?
Keep in mind, these drugs were developed to treat serious and potentially life threatening ailments. The active ingredient is modafinil, a drug that increases the neuralhormone dopamine, similar to standard amphetamines. The difference is that it doesn’t seem to have the jittery affect of most stimulants and has been described to more have the effect of “wakefulness”. This is supposed to help curb the effects of Narcolepsy and sleep apnea.
Narcolepsy is a debilitating affliction that causes spontaneous bouts of deep sleep that keeps the sufferer from driving, opportunities in a great number of professions, and the inability to move through normal society without fear of a sudden attack.
Sleep apnea, on the other hand, is a sleep disorder that keeps the sufferer from reaching deep sleep thus depriving them of the proper rest required to be fully productive during the day. The lack of rest accumulates leaving them in a constant fog and never fully awake. It is also associated with a breathing disorder that can affect the overall health of the sufferer.
Millions of business and leisure travelers who fly internationally or over many time zones suffer from jet lag. It’s a reaction in which the body’s internal clock is out of sync with the time in one’s location, leading people to feel sleepy when they need to be awake, or alert when they should be sleeping. Nuvigil was not intended to shift the body’s clock to its new time zone, only to allow people to stay awake.
The problem is that this is a naturally occurring side effect of travel that people can prepare for by adjusting their clocks a couple of days prior to travel or adjusting their schedules at their destination to compensate for jet lag. Narcolepsy and sleep apnea on the other hand are medical conditions. Thus the FDA denial.
FDA Denial
Cephalon’s clinical trial to test Nuvigil for approval with the FDA involved 427 volunteers who were flown from the East Coast of the United States to France. They were then sequestered to a sleep lab for three days. Electrodes were placed upon each of their scalps. The trial showed, as reported by Cephalon, those who took Nuvigil were less sleepy during the French daytime than those who were given a placebo.
In a more subjective test, in which participants were asked how sleepy they felt, the drug also did better than placebo, but not as convincingly. It was this study that the FDA apparently took over the corporation’s study.
In a statement, Cephalon did not elaborate about why the F.D.A. had rejected its application, other than to say that the agency had questioned the “robustness” of the results of questionnaires that asked participants in the company’s clinical trial how sleepy they felt after taking the drug.
The FDA has a strict policy to not comment on applications it does not approve, but as stated above, wide distribution of the drug could cause the public at large to be exposed to a side effect that is almost specific to the drug itself and could cause permanent disfigurement, crippling, and death.
Provigil and Nuvigil Side Effects
The FDA has issued a warning to consumers about the dire physical side effects and also warns of psychological effects of Progivil and Nuvigil. The side effects are:
- Anxiety
- Mania
- Hallucinations
- Suicidal ideation (thoughts of suicide)
- Multi-organ Hypersenesitivity
- Angioedema (severe swelling)
- Stevens-Johnson Syndrome (SJS)
- Erythema multiforme
- Toxic epidermal necrolysis
The last three on the list are severe rashes that cover the body with blisters and festering open wounds that are susceptible to various infections and can last for weeks if caught early or can cause death if left for too long. For SJS, the sufferer is generally admitted immediately into the severe burn unit in the hospital and quarantined to avoid infection.
Provigil and Nuvigil Lawsuits
It looks like staying awake on a business trip is going to have to stick with the FDA approved mainstay, coffee. Coffee may stain your teeth, but at least you won’t get permanently disfigured drinking it.
Regardless, Cephalon won’t stop trying to get Provigil and Nuvigil approved for the various other off label “cures” such as chronic fatigue, hangovers, restlessness, and being the president. They have already proven that they will do what it takes to keep their billion dollar baby young.
Yesterday a federal judge turned down Cephalon’s request to dismiss antitrust lawsuits against the company, which were filed by the Federal Trade Commission (FTC) and various private parties. The FTC and the other plaintiffs said that Cephalon had paid generic drug companies to delay generic competition for Provigil until 2012. The company said its agreements with the generic companies were legal and sought to have the lawsuits dismissed.
Paying companies to not profit doesn’t sound that cost beneficial. The bad news and questionable business practices probably fueled the reason why Cephalon’s shares fell 4 percent in early after-hours trading after rising 3 percent in regular trading on Monday.
All in all, their woes don’t stack up to the struggles of the victims of their side effects. If you or someone you know have suffered from Stevens-Johnson Syndrome, another type of disfiguring rash, or the debilitating mental side effects of the drug leading them to serious personal injury it is important you find council experienced in Defective Drug Litigation. Call Phillips Webster for a consultation on your legal options.
Learn More About:
