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Diet Pill Nears Over-the-Counter OK; Fat-Blocking Medication Seeks FDA Approval

Posted on: Tuesday, 24 January 2006, 15:00 CST

By ANDREW BRIDGES, THE ASSOCIATED PRESS

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

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

A joint FDA advisory committee voted 11-3 to recommend approval late Monday following 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 were given 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.

The pill's effect ends once its use is stopped, however, 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.

"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," panel chairman Dr. Alastair Wood said following the vote.

The panel requested that the company conduct follow-up 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 the overweight slim down only when combined with a diet and exercise regimen. The drug's actual effect on weight loss is "gradual and modest," said Steve Burton, Glaxo's vice president of weight control.

"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," said John Dent, the pharmaceutical company's senior vice president of research and development.

Dr. Sidney Wolfe of the watchdog group Public Citizen urged the panel to reject the company'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, told the panel: "We need this new solution to losing weight and keeping it off."

"Eat less, move more: It sounds pretty simple, doesn't it? Well, as my kids say, not!" said Fisher, adding that she's dieted for 45 of her 52 years.

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 5 million to 6 million Americans a year would buy the drug if offered over the counter.

Those numbers could mean at least $1.5 billion a year in retail sales.

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(SIDEBAR)

About orlistat

RECOMMENDATION: A Food and Drug Administration advisory committee voted 11-3 to recommend the approval of over-the-counter sales of a prescription weight-loss pill.

NEXT STEP: A nonprescription version of GlaxoSmithKline's orlistat, a drug already marketed in prescription form as Xenical, still needs final FDA approval.

NEW RULING: The FDA has never approved any nonprescription weight- loss drugs for sale.

Source: Record, The; Bergen County, N.J.

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