Cephalon Inc, Frazer, Pa, plans to file a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) to expand the indications for NUVIGIL® (armodafinil) Tablets. This comes after recent positive results from a phase three clinical trial of the drug for the treatment of excessive sleepiness associated with jet lag disorder.
The phase three trial was a randomized, double-blind, placebo-controlled study of 427 healthy adults who had experienced symptoms of jet lag during the previous 5 years. The subjects were flown from the United States to France and were then evaluated.
“After flying the subjects over the Atlantic, we objectively evaluated those receiving placebo versus those receiving NUVIGIL,” says Lesley Russell, MBChB, MRCP, 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. We are pleased that this positive study will allow us to file our first sNDA for an acute use of NUVIGIL.”
Currently, NUVIGIL is for the treatment of excessive sleepiness associated with obstructive sleep apnea/hyponea syndrome, shift work sleep disorder, and narcolepsy. The FDA approved NUVIGIL in 2007.