GlaxoSmithKline Consumer Healthcare was recommended an approval from the US FDA's Joint Non-prescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee for orlistat 60 mg capsules for over-the-counter (OTC) use in the United States.
OTC orlistat, which GSK proposes to market under the brand name Alli would be indicated for use by overweight adults along with a reduced calorie, low-fat die, states a GSK release.
"We are encouraged by the committee's recommendation for approval of what would be the only FDA-approved safe and effective OTC weight-loss aid for overweight adults. We look forward to working with the FDA to gain final approval," said George Quesnelle, president, GlaxoSmithKline Consumer Healthcare, North America
Unique among weight loss medications, orlistat is non-systemic. It does not affect the central nervous system, and has no effect on the heart or the brain.
Orlistat is a weight-loss medication that is taken with meals to inhibit the absorption of dietary fat. Orlistat should be used in conjunction with a reduced calorie diet that contains no more than 30 per cent of calories from fat. Following such a diet maximises weight loss and minimises unwanted gastrointestinal treatment effects, informed the release.
The safety and efficacy of orlistat, which has been marketed as a prescription drug in the US 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 22 million people in 145 countries have used orlistat.
Currently, 65 per cent (or approximately 130 million) of US adults are overweight or obese, according to the National Institutes of Health. Overweight and obesity are associated with an increased risk of developing health problems such as hypertension, type 2 diabetes and heart disease.
GSK Consumer Healthcare is one of the world's largest over-the-counter consumer healthcare products companies.