WASHINGTON – The Food and Drug Administration on Tuesday approved a new weight loss drug from Vivus Inc. that many doctors consider the most effective therapy in a new generation of anti-obesity pills designed to help patients safely shed pounds.
The agency cleared the pill Qsymia for adults who are obese or overweight and have at least one weight-related condition such as high blood pressure, diabetes or high cholesterol.
Patients taking Qsymia for a year lost 6.7 percent of their body weight in one study and 8.9 percent in another study, the FDA said. That was more than two other weight loss pills recently reviewed by the FDA.
Despite its impressive performance in clinical trials, Qsymia is not exactly a scientific breakthrough, and its development underscores the slow pace of research for obesity treatments.
The drug is actually a combination of two older drugs that have long been known to help with weight loss: phentermine and topirimate.
Phentermine is a stimulant that suppresses the appetite, and has long been used for short-term weight loss. Topiramate is an anticonvulsant, sold by Johnson & Johnson as Topamax, that makes people feel more satiated after eating.
Researchers say the Qsymia innovation lies in targeting multiple brain signals that drive overeating.
Qsymia is the second weight loss drug approved by the FDA in less than a month, following Arena Pharmaceutical’s pill Belviq in late June. The agency last approved a new drug for long-term weight loss in 1999.
The FDA initially rejected Vivus’ drug in 2010 over concerns that it can cause birth defects if taken by pregnant women. The agency laid out a risk-management plan Tuesday specifically designed to minimize the chance of the women becoming pregnant while using the drug.
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