Cephalon has presented promising late-stage data on Nuvigil, its follow-on from the blockbuster Provigil, which suggests that the drug can alleviate the symptoms of jet lag.
Nuvigil (armodafinil) was evaluated in a Phase III trial as a treatment for excessive sleepiness associated with jet lag disorder. The trial studied 427 adults who had experienced jet lag symptoms during the previous five years during a three-day period.
The participants travelled eastbound from the USA to France where they were then examined at a sleep facility. Patients taking Nuvigil 150 mg showed a statistically significant improvement over placebo and the results of this study will be submitted for presentation at a future medical meeting.
Lesley Russell, Cephalon’s chief medical officer, said that “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, the firm will file a supplemental New Drug Application with the US Food and Drug Administration to expand the indications for Nuvigil during the third quarter.
The drug is already approved, but not yet launched, in the USA to treat excessive sleepiness associated with narcolepsy, obstructive sleep apnoea/hypopnoea syndrome and shift-work sleep disorder. Nuvigil is a longer-acting version of Provigil (modanafil), which had 2008 sales of $988 million. The latter goes off-patent in 2012.
