GlaxoSmithKline: FDA committee will review over-the-counter Xenical next month

By E. Janene Geiss

Philadelphia, Dec. 9 - GlaxoSmithKline Consumer Healthcare said it anticipates its proposed over-the-counter use of orlistat (tetrahydrolipstatin) 60 mg capsules to promote weight loss in overweight adults will be reviewed by the Food and Drug Administration's joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committees on Jan. 23.

GlaxoSmithKline has filed a New Drug Application for use of the drug along with a reduced calorie, low-fat diet.

"Overweight and obesity are reaching epidemic proportions in the U.S., triggering a cascade of related health issues," John Dent, senior vice president, Research and Development, said in a company news release.

"This advisory committee review is an important step toward a safe and effective OTC weight-loss aid. We have a long and successful history of taking prescription products over-the-counter in a responsible manner, as with NicoDerm CQ and Nicorette, and we will work with the FDA to assure appropriate use for OTC orlistat 60 mg," Dent said.

The safety and efficacy of orlistat, which has been available as the prescription drug Xenical 120 mg in the United States since 1999, is supported by more than 100 clinical studies conducted in more than 30 countries, including the four-year landmark Xendos trial, the longest study ever of a weight loss medicine. More than 21 million people in 145 countries have used orlistat, officials said.

Orlistat is a non-systemic that works by inhibiting the absorption of dietary fat in the gut. Orlistat should be used in conjunction with a reduced-calorie diet that contains 30% fat or less, officials said.

GlaxoSmithKline Consumer Healthcare promotes Xenical in the United States following an agreement with Roche and has filed an application with the FDA to sell orlistat 60 mg over-the-counter. Roche retains marketing rights to orlistat outside the United States, officials said.

Orlistat 120mg capsule will remain available by prescription for the prevention of weight regain and the maintenance of weight loss for those who should be treated under the care of a physician, such as children and those with co-morbidities, officials said.

GlaxoSmithKline, based in London, is a pharmaceutical and consumer health care company.

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