“We’re Exploring Its Possibilities To Treat Excessive Sleepiness Associated With Schizophrenia, Bipolar Depression, Traumatic Injury, And Jet Lag”

In her 2009 New Yorker article about neuroenhancers, Margaret Talbot explains the concept of “mission creep,” whereby a pharmaceutical created for one purpose is pushed into other more suspect treatment areas by drug companies looking to further monetize a product:

“The Lynches said that Provigil was a classic example of a related phenomenon: mission creep. In 1998, Cephalon, the pharmaceutical company that manufactures it, received government approval to market the drug, but only for ‘excessive daytime sleepiness’ due to narcolepsy; by 2004, Cephalon had obtained permission to expand the labelling, so that it included sleep apnea and ‘shift-work sleep disorder.’ Net sales of Provigil climbed from a hundred and ninety-six million dollars in 2002 to nine hundred and eighty-eight million in 2008.

Cephalon executives have repeatedly said that they do not condone off-label use of Provigil, but in 2002 the company was reprimanded by the F.D.A. for distributing marketing materials that presented the drug as a remedy for tiredness, ‘decreased activity,’ and other supposed ailments. And in 2008 Cephalon paid four hundred and twenty-five million dollars and pleaded guilty to a federal criminal charge relating to its promotion of off-label uses for Provigil and two other drugs. Later this year, Cephalon plans to introduce Nuvigil, a longer-lasting variant of Provigil. Candace Steele, a spokesperson, said, ‘We’re exploring its possibilities to treat excessive sleepiness associated with schizophrenia, bipolar depression, traumatic injury, and jet lag.’ Though she emphasized that Cephalon was not developing Nuvigil as a neuroenhancer, she noted, “As part of the preparation for some of these other diseases, we’re looking to see if there’s improvement in cognition.'”

Another post about Nuvigil:

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