Back in July, an FDA advisory panel voted not to recommend obesity drug Qnexa for government approval because of concerns about cardiovascular risks, memory loss and suicidal thoughts in people taking it, and potential harm to the fetuses of pregnant women. Two months later, the drug’s manufacturer, Vivus, has reason to feel a little smug.Results of a two-year trial involving 675 overweight or obese patients show that Qnexa recipients who took a high dose lost an average of 11.4% of their body weight, compared with the 2.5% lost by people taking a placebo. A third group took a more moderate dose of the drug and lost 10.4% of their body weight. This follows medical guidelines that major weight loss is more effective when it happens slowly. (More on Time.com: Why Americans Are Fat: We Literally See More Food as Less)
Vivus said the study results show there is no evidence of patients attempting suicide or reporting suicidal thoughts, and Qnexa’s effects on heart rate were small. It said problems like cognitive and heart problems, sleep disorders, and depression were less common in the second year of testing.
As a result, Vivus stock went up on Tuesday, but it remains to be seen whether the new results will sway the FDA in the face of the advisory panel’s vote of no-confidence. A decision is set for October 28.
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