- The Washington Times - Monday, January 23, 2006

Two advisory panels to the Food and Drug Administration yesterday jointly recommended over-the-counter sales of the diet drug orlistat, deciding it would be both safe and effective, by a vote of 11-3.

If the FDA adopts the recommendation of the outside advisory panels, orlistat — whose trade name is Xenical — would be the first federally endorsed weight-loss drug that could be sold without a prescription, at a time when two-thirds of American adults are overweight or obese.

Recommendations of advisory committees are nonbinding, but the FDA usually supports them.

A prescription version of the panel-sanctioned weight-loss treatment, known generically as orlistat, has been on the market since 1999. The drug works in the digestive system and thwarts the body’s absorption of fat by blocking the digestion of about a third of the fat in food. Instead, the fat is excreted.

But prescription orlistat has some unpleasant digestive side effects, including diarrhea.

University of Pittsburgh researchers who studied over-the-counter use of orlistat as part of the application by the pharmaceutical firm GlaxoSmithKline, however, said they found that 50 percent of users had no side effects. Those who did managed by changing their diets or the way they took the medicine, the researchers said.

The stakes were high for company with this application. In 2004, the company paid Switzerland’s Roche Holdings Inc. $100 million for the right to sell orlistat over the counter.

The company plans to market the drug under the name Alli, pronounced “ally,” saying its use should be allied with a low-fat and reduced-calorie diet, vitamin supplements and exercise.

The application considered yesterday by a joint meeting of two FDA advisory committees — the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee — was for a lower-dose version of the prescription medication. The recommended nonprescription dosage is 60 milligrams daily for six months. The prescription dose is 120 milligrams.

Even so, company officials said the halved over-the-counter dose of orlistat over six months would result in 80 percent to 85 percent of the weight loss experienced using the prescription medicine. The latter leads to an average loss of 12.4 pounds over 12 months, when used with a diet and exercise plan, the company said.

The panels’ overwhelming endorsement of over-the-counter (OTC) sales of orlistat was something of a surprise, given the negative reviews that the drug received from FDA staffers. In published reports, some weight-loss specialists predicted that it would be rejected.

A review posted on the FDA Web site Friday challenged the notion that taking the 60 mg OTC dose for six months would be beneficial.

“It is not clear to this reviewer what benefit a consumer purchasing orlistat OTC can possibly reap from six months of OTC use,” the author said.

The FDA reviewer said that only about half of the patients taking the over-the-counter dose of orlistat lose two pounds monthly on the six-month therapy.

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