VIVUS announces results of Qnexa clinical study on cardiometabolic disease

VIVUS, Inc.Dec 9 2011

VIVUS, Inc. (NASDAQ: VVUS) today announced that results from the SEQUEL study were published in The American Journal of Clinical Nutrition, a peer-reviewed journal with broad, multidisciplinary readership. The SEQUEL study evaluated the long-term efficacy and safety of Qnexa in 676 overweight and obese subjects with cardiometabolic disease. In addition to 10% sustained weight loss, the study also found that significantly more placebo patients became diabetic over the two years as compared to patients treated with Qnexa. The data suggest that Qnexa, in conjunction with lifestyle modification, may provide a well-tolerated and effective option for the sustained treatment of obesity and the potential to prevent many in this population from progressing to type 2 diabetes.

"Recent data show that diabetes, like obesity, has become a rapidly growing epidemic, with nearly 1 in 10 adults potentially affected by the disease," said lead investigator W. Timothy Garvey M.D., director of the Nutrition Obesity Research Center, University of Alabama at Birmingham. "Results from the SEQUEL study underscore Qnexa's potential as a non-surgical option for sustained weight loss and improvements in comorbidities in overweight and obese patients."

Specific results as published in AJCN are as follows:

• Patients treated with Qnexa had significant, sustained weight loss compared to those in the placebo group over two years. 
• Average weight loss at week 108 was -9.3% and -10.5%, respectively, for the mid- and top-dose as compared to -1.8% for the placebo group (least-squares mean ITT-LOCF).
• Qnexa patients had improved cardiovascular and metabolic risk factors and a decrease in the need for associated medications in comparison with the placebo group.
• Placebo patients had a three times greater likelihood to progress to type 2 diabetes compared to subjects receiving top-dose Qnexa and a two times greater likelihood than patients on mid-dose Qnexa.

Qnexa therapy was well tolerated, with no new adverse events observed in the second year of study. The most common side effects were upper respiratory infection, constipation, tingling, sinus infection, dry mouth and runny nose. There were no drug-related serious adverse events reported. The completion rate in SEQUEL was approximately 83% for both Qnexa doses and 86% for the placebo group. Discontinuations due to adverse events were 4.5% and 4.4% for the mid- and top-dose, respectively, and 3.1% for the placebo group.