The anti-obesity drug Xenical, which never quite lived up to its original hype, may get a new lease on life by becoming the first weight-loss medication to move from prescription to over-the-counter status.
GlaxoSmithKline has asked the U.S. Food and Drug Administration for permission to sell a low-dose (60 mg) version of Xenical (orlistat) over the counter, and the application will be reviewed during a joint meeting of FDA’s Nonprescription Drugs and Endocrinologic & Metabolic Drugs advisory committees Jan. 23.
GlaxoSmithKline acquired the nonprescription marketing rights to Xenical from Roche in July 2004. Xenical currently is available by prescription at a 120 mg dose.
Researchers reported at a recent meeting of the North American Association for the Study of Obesity that 36 percent of overweight people taking the low-dose version of Xenical lost more than 5 percent of their initial body weight, compared with 28 percent of people taking a placebo.
Xenical was approved as a prescription drug in 1999, with studies showing that the drug -- which works in the gut by inhibiting absorption of dietary fat -- could increase weight loss by 50 to 80 percent when dieters use it faithfully. It currently is the No. 1 selling prescription weight-loss medication.
But Xenical also can alter bowel habits and cause diarrhea and gas, as well as oily spotting. It can also decrease the absorption of fat-soluble vitamins.
Other sources: Alli Report
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