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.

Steven Burton, vice president of weight control for GlaxoSmithKline Consumer Healthcare, said it makes sense to market an over-the-counter product like Xenical for the millions of consumers concerned about their weight.

"People want and need help," Burton said. "But many consumers, for a variety of reasons, don't or won't talk to their doctor about their weight status.

A measure of the potential U.S. market for OTC Xenical may be found in New Zealand, where sales of the drug have almost doubled since it was made available without prescription in mid-2005.

But some in New Zealand have suggested that it was being marketed to people who really did not need it, and discussion at the FDA advisory committee meeting may focus on the potential use or misuse of the drug’s OTC version in adolescent populations