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FDA panel recommends approval for OTC orlistat 60 mg
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Patients who are overweight or obese may soon have a new over-the-counter weight loss treatment.
At a meeting in January, the joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee voted 11-3 in favor of recommending orlistat 60 mg (Alli, GlaxoSmithKline) for approval as an over-the-counter (OTC) weight loss treatment.
If final approval is given, orlistat 60 mg will be the first weight loss drug available approved as an OTC treatment in the United States.
Although the FDA usually follows the approval recommendations of its advisory committees, it is not required to do so. A final decision is expected within the next few months.
The committee made its decision after reviewing data about orlistat 60 mg, including clinical trials examining the drug’s efficacy.
In one six-month trial, patients who were obese were treated with either orlistat 60 mg or a placebo. At the end of six months, patients treated with orlistat 60 mg lost an average of 5.3 pounds to 6.5 pounds more than the patients who were given the placebo.
A higher dose of orlistat did not appear to have a significantly increased benefit. Studies showed that a weight loss of 5% or more was achieved by 42% of overweight patients who took a 60-mg dose of orlistat and 45% of patients who took a 120-mg dose. Among those taking placebo, 23% achieved this level of weight loss.
Long-term use
Several committee members expressed concern about long-term use. Officials from GlaxoSmithKline said the company is recommending patients use the drug for no more than six months. But as an OTC drug, there would be no way to monitor the extent of patients’ use.
There was also concern about the long-term effectiveness and benefits of the drug, particularly if patients stop using it after six months. Previous studies have indicated that weight gain is common after patients discontinue use of the drug. Representatives from GlaxoSmithKline said the drug should be used in combination with lifestyle modification, including improved diet and increased physical activity. They said orlistat 60 mg is also intended to have a “gradual and modest” effect on weight loss.
Most committee members said they were in favor of having an approved OTC treatment for overweight and obesity because it would be preferable to the many dietary supplement products that are currently promoted as weight loss medication. – by Jay Lewis