Cephalon Inc. says it is abandoning its attempts to get its drug Nuvigil approved as a treatment for jet lag after the Food and Drug Administration issued another complete response letter.
Nuvigil already is approved to treat narcolepsy, excessive sleepiness caused by sleep apnea, and changes in work schedule. The Frazer-based company had submitted a supplemental new drug application to market the drug for jet lag, specifically for people traveling east.
Cephalon also had received a complete response letter, an indication that more information is needed, regarding Nuvigil in March, expressing the same concerns regarding patient-reported data.
"However, following several conversations with the agency, and given this second complete response letter, the company believes that further communications with the FDA will not result in an approval of this application," said Lesley Russell, Cephalon's chief medical officer.
"As a result, the company is no longer pursuing this indication."
A company spokeswoman said that Cephalon is still pursuing trials for Nuvigil's use in bipolar patients.
Cephalon shares were trading this morning at $63.34, down 66 cents. - Roslyn Rudolph