Healthcare Industry News: Topiramate
News Release - May 1, 2013
New Guidelines From American Association of Clinical Endocrinologists Recommend Medical Treatment of ObesityFirst Guidelines to Incorporate Anti-Obesity Medications as Recommended Treatment for Cardiometabolic Diseases
MOUNTAIN VIEW, Calif., May 1, 2013 -- (Healthcare Sales & Marketing Network) -- A new comprehensive treatment algorithm for diabetes from the American Association of Clinical Endocrinologists (AACE) is the first to recommend active obesity management, which includes lifestyle modification and, if appropriate, the use of FDA-approved anti-obesity medications, as first-line therapy in the management of chronic cardiometabolic diseases, including prediabetes, diabetes, dyslipidemia and hypertension.
"As a respected and influential institution in the field of endocrinology, it is encouraging to see the AACE has addressed the critical role of effective medical obesity treatments in the management of chronic cardiometabolic disease," said Peter Tam, president of VIVUS, Inc. (VVUS) "Endocrinologists are the thought leaders in weight management and metabolic diseases, and we believe that healthcare providers, including primary care physicians, along with payors and public policy makers, will recognize the significance of these new guidelines."
The AACE Comprehensive Diabetes Management Algorithm 2013 will be presented and discussed during the AACE 22nd Annual Scientific and Clinical Congress, May 1 -- 5, 2013 in Phoenix, AZ. The guidelines are available online and in the March/April 2013 issue of Endocrine Practice.
Qsymia(R) (phentermine and Topiramate extended-release) capsules CIV 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 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 and are subject to risks, uncertainties and other factors, including risks and uncertainties related to whether healthcare providers, payors and public policy makers will recognize the significance of the new AACE guidelines; risks and uncertainties related to the implementation of the modified REMS program and our ability to certify and sell Qsymia through certified retail pharmacies in the anticipated time, or at all; and risks and uncertainties related to our ability to develop and deploy effective educational programs and direct-to-consumer advertising that along with increased access to Qsymia and ongoing improvements in reimbursement will result in the accelerated adoption of Qsymia. These risks and uncertainties could cause actual results to differ materially from those referred to in these forward-looking statements. The reader is cautioned not to rely on these 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. VIVUS does not undertake an obligation to update or revise any forward-looking statements.
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