Brave Neuro World - Pharmaceutical Executive

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Brave Neuro World
Cosmetic neurology is a massive off-label market, but pharma has tended to look the other way. FDA may be about to change all that


Pharmaceutical Executive




Is President Obama popping the stimulant Provigil? The gossipy Daily Beast Web site floated that question in February following the release of the president's annual medical exam, including the notation "jet lag/time zone management, direct physician prescribed program, occasional medication use." The Cadillac of cognitive enhancers, Provigil has a narrow indication (excessive daytime sleepiness associated with narcolepsy, sleep apnea, and shift work), but a wide off-label reach because it is generally viewed as improving on the drawbacks of Ritalin and other amphetamine-type drugs—less of a rush and crash, fewer jitters, and allegedly minimal abuse or addiction potential. The little white pill with the sleek name comes closer than any other drug to conferring control over the body's sleep cycle.

That there is a significant craving for such control, especially among professional elites in a world increasingly defined by frequent global travel and a nonstop stream of digital information is abundantly evident. Approved in 2002, Provigil has enjoyed phenomenal sales growth: $5 million in 2005, $1 billion in 2009, and projections of $7 to $10 billion by 2018. Along the way, it has turned Cephalon into a top-10 biotech. The Philadelphia-based firm has returned the favor by nearly tripling the pill's price, a move that scarcely made a dent in its off-label use, which accounts for 90 percent of all prescriptions.

Boosting the brain artificially is as commonplace as the consumption of caffeine and nicotine, but the off-label use of drugs for lifestyle enhancement remains officially off-limits. The medical establishment, the drug industry, and FDA have all strictly hewed to the time-honored disease model of healthcare. Yet after a decade in which consumer demand has risen to a din, Provigil—or, more specifically, Nuvigil, the new longer-acting version—may prove to be the tipping point, the right drug at the right time to shatter the old paradigm. Last year, Cephalon applied for the first "medical treatment" for "jet lag disorder," potentially opening the floodgates to the first neuro-lifestyle indication and a market of tens of millions of travelers.

The significance that FDA attaches to this decision was signaled by its granting the submission "priority review" status typically reserved for serious or rare diseases. The agency's ambivalence about approval may explain why it then missed the deadline by months.

"FDA is in a real quandary," says Anjan Chatterjee, professor of neuroscience at the University of Pennsylvania medical school. "If they open a regulatory door to cognitive enhancement, even a crack, the genie will be out of the bottle once. On the other hand, there's a larger public health imperative to do something because so many people are already using these drugs."


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