While jet lag may not be health crisis exactly, it sure can be a pain.
So who wouldn't want a pill to fight the doldrums caused by skipping too many time zones too fast? Well, the Food and Drug Administration.
The regulators just gave a second thumbs down to drugmaker Cephalon's application to sell Nuvigil as a remedy for jet lag. The medicine is already approved to fight narcolepsy and sleepiness related to shift work.
But the regulators weren't buying the evidence put forward by the company to prove the medicine's benefits in treating travelers' "excessive sleepiness" outweighed its risks. In March, the FDA turned down Cephalon's jet-lag application and questioned how good the data supporting it really were. Cephalon soldiered on, giving FDA more data.
But today the company said its response fell short. In a statement, Dr. Lesley Russell, Cephalon's chief medical officer, said:
[T]he company believes that further communications with the FDA will not result in an approval of this application. As a result, the company is no longer pursuing this indication.
The most common side effects for Nuvigil, include diarrhea, headache, insomnia and nausea, according to Cephalon.
The medicine has also been linked to rare but life-threatening skin rashes, including Stevens-Johnson syndrome, and carries a prominent warning about that risk. Finally, it should be said that the Drug Enforcement Administration has made Nuvigil a federally controlled substance because it has the potential for abuse and dependence.
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