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FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®
Date:10/28/2010

are overweight with co-morbidities. Obesity is a chronic condition defined by having excess body fat. Obesity significantly increases the risk of developing many different diseases and health conditions, including type 2 diabetes, hypertension, metabolic syndrome, cardiovascular disease, some cancers and osteoarthritis. According to a report in The Lancet in 2009, morbid obesity shortens life expectancy by approximately 10 years, and moderate obesity shortens it by approximately 3 years.

Beyond its impact on health, obesity accounts for 9.1% of US annual health care spending – nearly $150 billion. By 2030, if trends in the escalating rates of obesity continue, healthcare costs attributable to obesity may reach $956 billion, accounting for up to 18% of total health care costs or $1 of every $6 spent on health care.

In August of this year, the CDC called attention to the "major public health problem" of obesity by issuing a national report citing the lack of progress against goals established 10 years ago by the federal government. The agency reported that all 50 states failed to meet the "Healthy People 2010" goal of lowering the obesity rate to 15%, and some states actually reported a significant increase in obesity rates. The agency includes obesity among six areas of focus in its "Winnable Battles" campaign to identify strategies, resources and partnerships to accelerate a measurable impact on health.

About VIVUSVIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead product in clinical development is QNEXA®, which also is in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction. For more information about the company, please visit

SOURCE VIVUS, Inc.
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