Ronette L. Kolotkin, PhDAuthors:
Kolotkin, Peterson, GaddeTitle:
Improvements in Quality of Life With Low-Dose, Controlled-Release Phentermine/Topiramate in Overweight/Obese Subjects (Abstract # 212896; Poster # 493-P)About QNEXA Controlled Release CapsulesQNEXA [kyoo-nek-suh] is an investigational drug being developed to address weight loss, type 2 diabetes and obstructive sleep apnea. QNEXA is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine and topiramate, which together decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impact eating behavior. In phase 2 and 3 clinical data to date, patients taking QNEXA have demonstrated statistically significant weight loss, glycemic control, and improvement in cardiovascular risk factors, when used in combination with a diet and lifestyle modification program.
VIVUS submitted a New Drug Application (NDA) to the FDA in December 2009 seeking approval of QNEXA for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity. An action date has been set for October 28, 2010.
About ObesityApproximately one-third of American adults (more than 72 million people) are obese, and many more 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, an
|SOURCE VIVUS, Inc.|
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