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Panel Favors Diet Drug for Over-Counter Sale

Posted on: Friday, 27 January 2006, 12:00 CST

By ANDREW BRIDGES Associated Press

FDA advisers view the weight-loss pill, now sold only by prescription, as OK for general use.

WASHINGTON -- Federal health advisers voted Monday to recommend over-the-counter sales of a weight-loss pill now sold only by prescription.

GlaxoSmithKline Consumer Healthcare still needs final Food and Drug Administration approval before it can sell a nonprescription version of orlistat, a diet pill marketed in prescription form as Xenical. The FDA gave approval in 1999 to the prescription version of the fat-blocking pill made by Roche.

A joint FDA advisory committee voted 11-3 to recommend approval late Monday after a daylong hearing. The agency usually follows the recommendations of its outside panels of experts, but its final decision could take months.

If approved, orlistat would be the first weight-loss drug sanctioned for over-the-counter sales.

In six-month clinical trials, obese people who took orlistat lost on average 5.3 pounds to 6.2 pounds more than did those who got dummy pills. Glaxo wants people to use it for only six months at a time, but as an over-the-counter item, its use could not be policed.

However, the pill's effect ends once its use is stopped, said Dr. Julie Golden, a medical officer in the FDA's division of metabolism and endocrinology products. A previous study showed a progressive weight gain in patients after they discontinued use of orlistat, Golden said.

The panel's chairman, Dr. Alastair Wood, said after the vote: "I think the drug is safe enough to be OTC. It's an OTC indication. Although there are some i's that need to be dotted and t's crossed, it's suitable for OTC use."

The panel requested that the company conduct followup studies if and when the drug does reach the market, as well as rework the pill's label to ensure its proper use, Wood said.

Glaxo said the drug helps people slim down only when combined with a diet and exercise regimen. The drug's effect on weight loss is "gradual and modest," said Steve Burton, Glaxo's vice president of weight control.

John Dent, the company's senior vice president of research and development, said: "There is no magic pill for weight loss, and orlistat is not a magic pill. Orlistat is a tool that will help people control their calorie intake and modify their diet."

Dr. Sidney Wolfe of the watchdog group Public Citizen urged rejection of Glaxo's application, calling it a "desperate attempt to revive this barely effective drug by an OTC switch."

Deborah Fisher, a nurse from the Baltimore area who said she has dieted for 45 of her 52 years, told the panel, "We need this new solution to losing weight and keeping it off."

The proposed over-the-counter orlistat pill, called Alli (pronounced "ally"), would contain half the dose of the prescription capsule.

Alli could cost consumers $12 to $25 a week, Glaxo said. The company estimated that 5 million to 6 million Americans a year would buy the drug if it was offered over the counter. Those numbers could mean at least $1.5 billion a year in retail sales.

FDA panel members questioned Monday whether consumers would be able to distinguish Alli from non-approved dietary supplements also sold as weight-loss aids. They also expressed concern about its effect on vitamin intake. Half of the patients enrolled in trials of the drug failed to understand labeling directions that they should take supplemental vitamins at least two hours before or after using the pills.

The drug also could cause problems for organ transplant patients taking the drug cyclosporine as well as those using warfarin, a blood thinner. The drug's label would warn such patients against taking the weight-loss pill.

When taken with meals, orlistat blocks the absorption of about one-quarter of any fat consumed. That fat -- the equivalent of about 150 to 200 calories -- is passed out of the body in stools, which can be loose or oily as a result. Other side effects include gas, incontinence and oily spotting. About half of patients in trials had such side effects, the company said.

Furthermore, just 35 percent of diabetes patients in a study correctly stated that the drug was inappropriate for them, FDA documents show.

Those results worried FDA reviewers, who questioned the risk of selling the drug directly to consumers "without the principal involvement of a learned intermediary," or prescribing physician.

Food and Drug Administration:

www.fda.gov

GlaxoSmithKline:

www.gsk.com

Whats next

Recommendation A Foodand Drug Administration advisorycommittee voted 11-3Monday to recommend theapproval of over-the-countersales of a prescriptionweight-loss pill.

Next step A nonprescriptionversion of GlaxoSmith-Klines orlistat, a drug alreadymarketed inprescription form as Xenical,still needs final FDA approval.

New ruling The FDA hasnever approved any nonprescriptionweight- loss drug forsale.

Source: Tulsa World

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