Study Concludes That Weight Loss With Qsymia™ Significantly Improves Multiple Cardiovascular Disease Risk Factors
by PR Newswire
MOUNTAIN VIEW, Calif., Feb. 1, 2013 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS) announced today the publication of a study concluding that weight loss resulting from treatment with QsymiaTM (phentermine and topiramate extended-release) capsules CIV led to significant improvements in cholesterol, blood pressure and triglycerides in obese and overweight patients experiencing one or more of these associated conditions. The improvements were significantly greater among patients who lost 10% or more of their starting weight.
"This provides clear evidence that patients with hypertension or high cholesterol treated with Qsymia for one year experienced significant weight loss and clinically meaningful improvements in their underlying cardiovascular risk factors," said Suzanne Oparil, M.D., Director of the Vascular Biology and Hypertension Program, University of Alabama at Birmingham, and an investigator in the study. "The ability to improve underlying risk factors is another reason physicians should proactively discuss the medical treatment of obesity with their patients who have failed lifestyle modification alone."
Obesity is a chronic condition defined by having excess body fat. Obesity and smoking are the leading causes of preventable death in the U.S., and obesity contributes directly to numerous life-threatening conditions including diabetes, cardiovascular disease, hypertension and stroke. According to the World Health Organization and CDC, more than 500 million people worldwide and approximately one-third of American adults (more than 78 million people) are obese. In addition to obesity, high cholesterol, blood pressure and triglycerides are significant risk factors for cardiovascular disease.
About the Study
Participants in the study with body mass indexes of 27 to 45 kg/m2 were randomized to placebo, recommended dose (7.5/46mg) or top dose (15/92mg) Qsymia. Participants also received lifestyle modification counseling. Primary end points were percentage weight loss and the proportion of participants achieving at least 5% weight loss. Additional end points were changes in lipid variables in patients with dyslipidemia and changes in blood pressure in patients with hypertension, stratified by treatment assignment and magnitude of weight loss. Qsymia produced significantly greater dose-related mean percentage weight loss compared with placebo in the subgroups of participants with dyslipidemia and those with hypertension.
In the subgroup with dyslipidemia, treatment-emergent adverse events occurred in 75.9%, 86.5%, and 88.3% of the placebo, recommended dose, and top dose groups, respectively. In the subgroup with hypertension, the rates were 77.3%, 85.4%, and 88.8%, respectively. The most common treatment emergent adverse events in the subgroup with dyslipidemia and the subgroup with hypertension were dry mouth, paraesthesia, constipation, upper respiratory tract infection, and nasopharyngitis. Adverse event profiles in these high risk patients were similar to those seen in the study population as a whole.
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 pharmacy network; whether or not the FDA approves our amendment to the REMS for Qsymia, which, if approved, would allow dispensing through select 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; our appeal of 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 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 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, 2011, and periodic reports filed with the Securities and Exchange Commission.
SOURCE VIVUS, Inc.