Cephalon's supplemental NDA for Nuvigil to treat jet lag would, if approved, triple the on-label population for the product.

Nuvigil (armodafinil) is already approved in the U.S. for improving wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work sleep disorder and narcolepsy, which together affect more than 36 million Americans.

But it may soon get to add "improved wakefulness in patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel" to that list, something that affects nearly 70 million Americans each year.

Cephalon has plans to move Nuvigil into other, more established treatment categories as well. Lesley Russell, Chief Medical Officer and Executive Vice President at Cephalon, said Nuvigil is being examined for several other indications that could be submitted over the next five years, including traumatic brain injury, bipolar-1 disorder, negative symptoms of schizophrenia and cancer-related sleepiness.

A marketing challenge

If Nuvigil's jet lag indication is approved, it will be interesting to see how Cephalon decides to market it. The drug's current indications are all for chronic uses, but jet lag would be an acute use - something in which direct-to-consumer advertising may prove useful.

A Cephalon spokeswoman told "The Pink Sheet" it is too early to be thinking about specific marketing strategies as the company is still analyzing socio-economic impacts and the behavior profiles of potential jet-lag patients. She also said it is too early for sales forecasts if the new indication is approved.

Nuvigil - the longer-lasting form of Provigil (modafinil), which goes off-market in 2012 - was approved in June 2007 for its current indications.

Currently, there are no FDA-approved medications to improve the side effects of jet lag, and since Nuvigil was just recently approved for its other indications, it is too early to tell if the drug is being used off-label, the firm said.

Typically, those suffering with jet lag are given hypnotics on an off-label basis, including non-benzodiazepines such as Ambien , Lunesta and Sonata , or a benzodiazepine such as Halcion . And while these drugs help sufferers sleep, they do nothing to improve daytime functioning. Cephalon is hoping that Nugivil will appeal to those who need to attend meetings or drive upon reaching their destination.

An east-bound test

The sNDA, submitted June 30, is based on data from a Phase III study, recently presented at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies. A randomized study of 427 men and women flying eastbound from the U.S. to France found that a 150-gram daily dose of Nuvigil improved excessive sleepiness associated with jet lag disorder, according to two measures - the Multiple Sleep Latency Test and the Patient Global Impression of Severity test (¹ Also see "Cephalon’s Nuvigil On Course For Jet-Lag Filing" - Pink Sheet, 6 April, 2009.).

Jet lag disorder is an acute condition that occurs when a person's internal body clock becomes disrupted as a result of rapid travel across several time zones. According to the Mayo Clinic, jet lag can cause daytime fatigue, an unwell feeling, difficulty staying alert and gastrointestinal problems.

The most common adverse events associated with Nuvigil were headache, nausea, diarrhea, and palpitations, which affected more than 5 percent of trial patients. However, its label includes a warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, that has been reported in adults and children taking modafinil.

-Lauren Smith (lauren.smith@elsevier.com)

Nuvigil Jet Lag Indication Could Triple Potential Patients

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