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.
Those who took Nuvigil showed a statistically significant improvement of jet-lag symptoms over those who took a placebo, Cephalon said.
"After flying the subjects over the Atlantic, we objectively evaluated those receiving placebo versus those receiving Nuvigil," said Dr. Lesley Russell, Chief Medical Officer and Executive Vice President at Cephalon. "We discovered that those on placebo were as excessively sleepy as narcoleptics and that the treatment effect for those on Nuvigil was the largest we have seen to date."
Based on the findings, Cephalon will file a supplemental New Drug Application with the U.S. Food and Drug Administration to expand the indications for Nuvigil during the third quarter of this year.
Jet lag disorder is an acute circadian rhythm sleep disorder that results from rapid travel across several time zones. This disorder affects approximately 70 million American travelers annually and gradually resolves once a person adjusts to the new local time.
Circadian rhythm sleep disorders are disruptions in a person's internal body clock, which controls sleep patterns. When the internal body clock is disrupted, certain symptoms may develop affecting a person's ability to sleep, stay awake and function normally. Circadian rhythm sleep disorders can be caused by many factors, including shift work, time zone changes and medications, Cephalon said.
"We do acknowledge that this is an acute condition that does resolve itself once someone does adjust to a local time zone," the company's spokeswoman Candace Steele told Sarah Rubenstein of the Wall Street Journal Still, she added, "there is a functional impairment for people who have jet lag disorder."
If the FDA gives its nod, Nuvigil would be the first prescription drug approved for such a use.