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Diet drug may go over the counter

Xenical would be the first of its kind to go from prescription use to pharmacy shelves.

October 24, 2005|Shari Roan | Times Staff Writer

Drugstore shelves are brimming with shakes, herbs and other products to facilitate weight loss -- but the vast majority of them have not been shown to work. It's possible that a proven medication that helps modestly with weight loss may join their ranks next year.

The pharmaceutical company GlaxoSmithKline has asked the Food and Drug Administration for permission to sell a low-dose version of its diet drug Xenical over the counter. If approved, Xenical would be the first weight loss medication to make the switch from prescription to nonprescription status.

In data presented last week at a national obesity meeting, researchers reported that 36% of overweight people taking a low-dose version of Xenical lost more than 5% of their initial body weight, compared with 28% of people taking a placebo. The researchers also found that users did not abuse the drug by, for instance, exceeding the maximum dose.

The application to sell Xenical over the counter -- filed with the FDA in June -- reflects the growing concern over American's obesity epidemic and the need to make a variety of weight-loss tools easily accessible to consumers, says Steven Burton, vice president of weight control for GlaxoSmithKline Consumer Healthcare, a division of the company. About 64% of U.S. adults are overweight or obese, and in such a climate, Burton says, it makes sense to market an over-the-counter aid. "People want and need help.... But many consumers, for a variety of reasons, don't or won't talk to their doctor about their weight status," he says.

Xenical, also known by the generic name orlistat, was approved as a prescription diet drug in 1999. The effect of the medication in the marketplace has been modest. Studies show the drug can increase weight loss by 50% to 80% when used faithfully. For example, a dieter who lost 10 pounds without medication might expect to lose 15 to 18 pounds if taking Xenical.

But the drug doesn't appeal to all dieters. It works in the gut by inhibiting absorption of dietary fat and can alter bowel habits and cause diarrhea and gas. Xenical can also decrease the absorption of fat-soluble vitamins, and users are advised to take a multivitamin.

"In my experience, the patients for whom Xenical has been effective have been those who say, 'It keeps me honest. It reminds me if I go off track, I will have a physical consequence,' " says Madelyn Fernstrom, director of the University of Pittsburgh Medical Center's Weight Management Center.

"But that will be a very small portion of the population. Most people are not going to stick with this."

The Xenical study was presented in Vancouver, Canada, at the annual meeting of the North American Assn. for the Study of Obesity, which last week changed its name to NAASO, the Obesity Society. Conducted by GlaxoSmithKline, the study included 391 people who were assigned to take either Xenical or a placebo. Both groups received self-instructional educational materials on weight loss.

Overall, 57% of the Xenical users lost 3% of their total body weight, compared with 42% of placebo users. Orlistat users who lost weight also had significant decreases in the total cholesterol, low-density lipoprotein (bad) cholesterol and blood pressure. About one-fourth of each group dropped out of the study.

A second GlaxoSmithKline study, also presented last week, reported that most people purchasing the product in one of 18 participating drugstores used it correctly. Only one person among the 237 subjects, who were aware they were part of a study, exceeded the recommended daily dosage. The majority of users followed advice on the product label to take a multivitamin. No one who was underweight bought the product, and 73% said they thought it helped them lose weight.

Fernstrom, who was not involved in the Xenical studies, expresses doubts about the direct-to-consumer route. She says most people do better if they receive some professional guidance when embarking on a weight loss plan -- and an over-the-counter pill would bypass this.

Burton says that if the over-the-counter version of Xenical (as yet unnamed) is approved, it would be sold with an educational booklet on how to implement a weight-loss program that includes diet and exercise. "We want to develop this not just as a pill but as a program," he says.

The product would be sold only to people 18 and older and is recommended for six months of use. No price has been set, but Burton said the daily cost would probably mirror what consumers spend "on a can of Coke or a bag of chips."

An FDA decision on the Xenical application is expected in the first half of 2006.

Other obesity findings

Here are some of the other scientific reports from last week's obesity conference:

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