MOUNTAIN VIEW, Calif., Oct. 21 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced that data on QNEXA®, an investigational drug candidate, will be featured in two oral presentations at the 1st International Diabetes and Obesity Forum, being held October 21-23, 2010 in Athens, Greece.
Following are details about the presentations:
The 1st International Diabetes and Obesity Forum in Athens, Greece
Both presentations will be made by Dr. Louis J. Aronne, MD, on Saturday October 23, 2010 from 2:00 to 3:30 pm in the Santorini Hall of the Hilton Athens.
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Authors: |
Aronne, Peterson, Troupin, Day |
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Title: |
ONCE-DAILY, CONTROLLED-RELEASE PHENTERMINE/TOPIRAMATE (PHEN/TPM CR) RESULTS IN SIGNIFICANT WEIGHT LOSS AND RISK FACTOR IMPROVEMENT IN OVERWEIGHT/OBESE SUBJECTS OVER 56 WEEKS |
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Authors: |
Aronne, Klein, Peterson |
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Title: |
AMOUNT OF CARDIOMETABOLIC RISK REDUCTION IS DIRECTLY ASSOCIATED WITH MAGNITUDE OF WEIGHT LOSS WITH LOW-DOSE, CONTROLLED-RELEASE PHENTERMINE/TOPIRAMATE (PHEN/TPM CR) |
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About QNEXA Controlled Release Capsules
QNEXA [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 Obesity
Approximately 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, and moderate obesity shortens it by approximately three years.
In August of this year, the Centers for Disease Control and Prevention (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 CDC 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.
About VIVUS
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead product in clinical development, QNEXA®, has completed phase 3 clinical trials for the treatment of obesity and an NDA has been filed and accepted by the FDA, with an action date of October 28, 2010. QNEXA is also 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. MUSE® (alprostadil), a first generation therapy for the treatment of ED, is already on the market and generating revenue for VIVUS. For more information about the company, please visit www.vivus.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on VIVUS' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2009 and periodic reports filed with the Securities and Exchange Commission.
SOURCE VIVUS, Inc.