MOUNTAIN VIEW, Calif., March 25, 2013 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS) announced today that a new study demonstrates that effective medical treatment providing 10% to 15% weight loss could lead to significant improvements in Medicare spending by reversing or reducing significant health consequences such as type 2 diabetes, hypertension and dyslipidemia in obese or overweight patients.
The study, conducted by Kenneth E. Thorpe , PhD, Professor and Chair, Department of Health Policy and Management, Rollins School of Public Health, Emory University, was published today online [http://www.healtheconomicsreview.com/content/pdf/2191-1991-3-7.pdf] in Health Economics Review. It is the first research to project the potential impact that a new generation of FDA-approved anti-obesity medications could have on Medicare spending among adults aged 65 and older who are either obese or overweight with at least one weight-related comorbidity such as hypertension or diabetes.
"America's weight problem is contributing to its spending problem," said Dr. Thorpe. "Including anti-obesity medications that can achieve this level of efficacy in the Medicare benefits package will fill the gap between lifestyle changes alone and bariatric surgery. It could save billions in lifetime Medicare spending."
"Obesity is a chronic condition that contributes to a number of comorbidities such as diabetes and hypertension, which are costly to treat," said W. Timothy Garvey , MD, Butterworth Professor and Chair, Department of Nutrition Sciences at the University of Alabama at Birmingham. "By targeting obesity as a key contributor to these conditions, we can improve patient outcomes and make a positive impact on the costs related to treating these comorbidities."
The study suggests that 10% to 15% weight loss in obese and overweight people could produce gross per capita savings ranging from approximately $6,000 to $13,000 over a 10-year period, depending on a variety of factors. Potential savings were even greater over a lifetime. Collectively, among the estimated 11.2 million Medicare patients who are obese or overweight with at least one weight-related comorbidity, the lifetime savings could total in the billions of dollars.
The study highlighted that weight loss produced by Qsymia® (phentermine and topiramate extended-release) capsules CIV demonstrated durability over a two-year period of treatment. The Qsymia mid and top dose led to greater weight loss results, and patients who adhere to a treatment regimen are more likely to achieve 10% to 15% weight loss and sustain it over time.
Qsymia is approved in the U.S. and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.
The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.
Important Safety Information
Qsymia (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.
Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.
The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.
VIVUS is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health for U.S., Europe and other world markets. Qsymia is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. 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," "estimate," "expect," "intend," "likely," "may," "plan," "potential," "predict," "opportunity" and "should," among others. 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, our limited commercial experience with Qsymia in the U.S.; the timing of initiation and completion of the clinical studies required as part of the approval of Qsymia by the United States Food and Drug Administration, or FDA; the response from the FDA to the data that VIVUS will submit relating to post-approval clinical studies; the impact of the indicated uses and contraindications contained in the Qsymia label and the Risk Evaluation and Mitigation Strategy, or REMS, requirements; the impact of distribution of Qsymia through a certified home delivery pharmacy network; whether or not the FDA approves our amendment to the REMS for Qsymia, which, if approved, would allow dispensing through select certified retail pharmacies to increase access while meeting all requirements of the REMS; that we may be required to provide further analysis of previously submitted clinical trial data; the negative opinion of the European Medicines Agency's, or EMA, Committee for Medicinal Products for Human Use, or CHMP, for the Marketing Authorization Application, or MAA, for Qsymia; our ability to successfully commercialize or establish a marketing partnership for avanafil, which will be marketed in the U.S. under the name STENDRA™; the ability of our partners to obtain and maintain regulatory approvals to manufacture and adequately supply our products to meet demand; our history of losses and variable quarterly results; substantial competition; risks related to the failure to protect our intellectual property and litigation in which we may become involved; uncertainties of government or third party payer reimbursement; our reliance on sole source suppliers; our limited sales and marketing and manufacturing experience; our reliance on third parties and our collaborative partners; our failure to continue to develop innovative investigational drug candidates and drugs; risks related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; our ability to demonstrate through clinical testing the safety and effectiveness of our investigational drug candidates; the timing of initiation and completion of clinical trials and submissions to foreign authorities; the results of post-marketing studies are not favorable; compliance with post-marketing regulatory standards is not maintained; the volatility and liquidity of the financial markets; our liquidity and capital resources; and our expected future revenues, operations and expenditures. As with any pharmaceutical in development, there are significant risks in the development, the regulatory approval, and the commercialization of new products. There are no guarantees that the product will receive regulatory approval outside the United States for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should read the risk factors set forth in VIVUS's Form 10-K for the year ending December 31, 2012, and periodic reports filed with the Securities and Exchange Commission.
|SOURCE VIVUS, Inc.|
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