FRAZER, Pa. The Food and Drug Administration declined to approve a Cephalon drug as a treatment for jet lag, the drug maker announced Monday.
Cephalon said it received a complete response letter from the FDA for Nuvigil (armodafinil) tablets. The company had been seeking approval for the drug, already approved for sleep apnea, as a treatment for excessive sleepiness associated with jet lag, particularly resulting from eastbound travel.
The FDA issues complete response letters when it has finished reviewing a drug, but issues remain that preclude the drug’s approval. Cephalon chief medical officer Lesley Russell said in a statement that the agency had raised questions about a subjective assessment of clinical efficacy called the patient global impression of severity, or PGI-S.