Jet Lag Drug

Nuvigil could become first drug specifically approved to combat jet lag.

On the front page of its Business Day section, the New York Times (1/7, B1, Pollack) reports, "Nuvigil [armodafinil] from Cephalon, could become the first medicine specifically approved by the Food and Drug Administration to combat jet lag." The drug "is a slight modification of Provigil, an older stimulant that will face generic competition in 2010." FDA approval is not only "part of a plan to extend patent protection for its core franchise in stay-awake drugs," but it would also "enable Cephalon to promote Nuvigil to a broad array of doctors."
Cephalon sues Watson over Nuvigil generic. The AP (1/6) reported, "Cephalon Inc. on Wednesday confirmed it is suing generic drug developer Watson Pharmaceuticals Inc. over" the "company's plan to make a generic version of Cephalon's sleep disorder drug Nuvigil [armodafinil]." Watson is seeking FDA approval for "various doses of a generic version of Nuvigil." The suit "triggers a mandatory waiting period that will prevent the FDA from approving generic Nuvigil for the next 30 months, or until a court makes a ruling on the lawsuit." Reuters (1/6) and the Philadelphia Business Journal (1/7, George) also cover the story.
Melatonin may help speed jet lag recovery. The New York Times (1/7, B10, Pollack) reports that experts say melatonin, a hormone that "appears to tell the body when it is night," may help make the body's internal clock "adjust faster to a new time zone, thereby speeding resolution of jet lag." But, "drug companies have little incentive to perform" trials "showing that melatonin can help combat jet lag," because "melatonin is not patented." Some drugmakers have created "patented compounds that mimic melatonin by binding to the same receptors in the brain as the hormone," such as Takeda Pharmaceutical's Rozerem [ramelteon], which is currently approved for insomnia.