When the advisory panel first reviewed the phentermine-topiramate combination in July 2010, the majority voted against approval because of concerns about associated teratogenicity and increases in heart rate (by a mean of 1.6 beats/min at the highest dose). At the FDA’s request, the company studied the cardiovascular risks and teratogenic potential further and developed the REMS.
Vivus is required to conduct 10 postmarketing studies, including long-term cardiovascular outcomes studies in overweight and obese people with cardiovascular disease, studies in obese children and adolescents, and studies to evaluate drug utilization and pregnancy exposures. The company expects to make the drug available in the fourth quarter of 2012.
This is the second drug product approved for weight loss in 13 years. In June, the FDA approved lorcaserin hydrochloride (Belviq), a selective serotonin 2C receptor agonist at a dosage of 10 mg twice a day for the same indication.
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