Xenical may be sold over-the-counter

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Xenical may be sold over-the-counter

LOS ANGELES TIMES

November 8, 2005

Drugstore shelves are brimming with shakes, herbs and other products

to help with weight loss, but the vast majority of them have not

been shown to work. A proven medication that helps modestly with

weight loss might join their ranks on the shelves next year.

The pharmaceutical company GlaxoKline 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 recently at a national obesity meeting,

researchers reported that 36 percent of overweight people taking a

low-dose version of Xenical in a small study lost more than 5

percent of their initial body weight, compared with 28 percent of

people taking a placebo. The researchers also found that users did

not abuse the drug by, for instance, exceeding the maximum dose.

Another weapon in the fight

The application to sell Xenical over the counter - filed with the

FDA in June - reflects the growing concern over Americans' obesity

epidemic and the need to make a variety of weight-loss tools easily

accessible to consumers, says Burton, vice president of

weight control for GlaxoKline Consumer Healthcare, a division

of the company. About 64 percent 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 percent to 80 percent 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.

Sticking to a diet is hard

" 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 Association for the Study of Obesity, which has just

changed its name to NAASO, the Obesity Society.

Conducted by GlaxoKline, 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 percent of the Xenical users lost 3 percent of their

total body weight, compared with 42 percent 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-quarter of each group dropped out of the

study.

A second GlaxoKline study, also presented at the obesity

meeting, 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 percent said they thought it

helped them lose weight.

Fernstrom of Pittsburgh, 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 of Consumer Healthcare says that if the OTC version of

Xenical 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 to people 18 and older, 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.