Back in January we told you about Cephalon’s submission of their sleep disorder drug, Nuvigil, to be approved as a treatment for jet lag by the FDA. The FDA has completed its review, but they have not approved the application because of questions pertaining to some of the data submitted. Cephalon is already following up with the FDA to clarify the points in question and we’ll continue to track its progress through the process.
Posts Tagged ‘Jet Lag’
No Approval Yet for the Jet Lag Drug
Thursday, April 29th, 2010 by Moira BishopJet Lag — the Target of the Latest Lifestyle Drug
Friday, January 8th, 2010 by Moira Bishop
If you could take a pill to manage your jet lag, would you? Would it be worth the possibility of dealing with headaches, nausea, dizziness or insomnia as side effects? Would you be willing to pay more than $9 per dose for this remedy?
Healthy travel takes more than packing a first aid kit and getting the destination-specific vaccinations that you need. It also includes putting into practice some preventative measures that will keep the journey from wearing down your body and immune system. This is particularly important if you are traveling overseas, as jet lag can leave your mind fighting to catch up with your body’s cycle the whole duration of your trip.
Now, pharmaceutical company, Cephalon, Frazer, PA, has submitted a jet lag solution to the Food and Drug Administration (FDA) for approval. The drug is an existing product, Nuvigil, which is used to treat serious sleep disorders and requires a prescription. According to a news release from Cephalon, this drug offers “improved wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel.” The New York Times reports that clinical trials did show improved levels of wakefulness for those given Nuvigil and that Cephalon is only seeking approval for this as a solution for eastbound travelers because the adjustment for westbound travelers is generally easier.
Those travelers who only occasionally take an overseas flight might fight the effects of jet lag by following the common practices of upping their post-flight caffeine intake and taking melatonin supplements. Business travelers and others who frequently travel overseas, however, might see Nuvigil as a valuable traveling companion. The FDA is expected to complete its review by March 29, 2010; stay tuned for updates.
Photo by Heart Industry http://www.flickr.com/photos/heartindustry/ / CC BY-NC 2.0
