14 DAY TRIAL // Frequent travelers know that one of the biggest annoyances they have to face each time they land is jet lag. Until not long ago, it was believed that jet lag was nothing more than just an upsetting occurrence that no one could do anything about, other than bear with it until it went away. Since research has shown that it’s actually a disorder, Cephalon has already come up with a cure for it in the form of Nuvigil, which is poised to become the first drug for jet lag.
“The efficacy and safety of Nuvigil as a potential treatment for acute excessive sleepiness associated with jet lag disorder were evaluated over the course of three days in a randomized, double-blind, placebo-controlled study of 427 healthy adults who had experienced jet lag symptoms during the previous five years. Participants in the study traveled eastbound from the United States to France where they were then examined at a sleep facility. Clinical efficacy was evaluated using two primary endpoints: an objective assessment – the Multiple Sleep Latency Test (MSLT), and a subjective assessment – the Patient Global Impression of Severity (PGI-S).” a statement from the company says.
At the same time, the statement adds that the exact, detailed results of the study have not yet been submitted for presentation. Yet, the initial numbers indicate that Nuvigil could be effectively used to treat jet lag in all sufferers, which would virtually put an end to this acute, circadian rhythm sleep disorder, as Cephalon classifies it.
Next up on the company’s to-do list is submitting the drug for approval with the FDA, after wrapping up the studies and drawing the line as to its efficiency with jet lag symptoms. However, as Goldman Sachs analyst Shibani Malhotra wrote in a note to investors, getting this approval for jet lag would mean Cephalon would be able to market Nuvigil to a broad range of doctors, which, in turn, might make “this indication be viewed as ‘lifestyle’ (less severe) and would enable use of the drug in a broader population.”
Cephalon spokeswoman Candace Steele is optimistic that Nuvigil will get approval for jet lag, since this is not a condition that should be disregarded just because it goes away, as she tells in a statement to the Health Blog. “We do acknowledge that this is an acute condition that does resolve itself once someone does adjust to a local time zone. [Still,] there is a functional impairment for people who have jet lag disorder.” Steele underlines.
If all goes according to plan, Cephalon intends to start marketing Nuvigil for jet-lag use in the latter part of 2009.