Trial for jet lag treatment has positive results, drugmaker says

FRAZER, Pa. A phase 3 clinical trial of a drug under investigation for treating jet lag has yielded positive results, the drug’s developer has announced.

Cephalon announced Monday that it will submit an approval application to the Food and Drug Administration for Nuvigil (armodafinil) based on the results of the study, which investigated the drug as a treatment for excessive sleepiness associated with jet lag.

The study was a randomized, double-blind, placebo-controlled study in which 427 healthy adults who had experienced symptoms of jet lag during the last five years. Participants flew from the United States to France, where they were examined at a sleep facility. Patients who took Nuvigil showed a statistically significant improvement over those who took placebo.

“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,” Cephalon chief medical officer and EVP Lesley Russell said.