MOUNTAIN VIEW, Calif., Oct. 31, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) announced today that a newly-published study demonstrated Qsymia® (phentermine and topiramate extended-release) capsules CIV produced significantly greater weight loss, and at lower doses, compared to phentermine or topiramate administered as monotherapies in obese adults. Among patients taking the once-daily extended-release formulation, Qsymia was generally well tolerated and improved blood pressure. In this study, the effect of Qsymia on heart rate was similar to placebo.
The 28-week study was published online in the journal Obesity.
Qsymia 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.
In the study, patients completing 28 weeks of treatment on Qsymia 7.5 mg/46 mg and 15 mg/92 mg were able to reduce their weight by 11% and 12%, respectively. Greater improvements in waist circumference, glycosylated haemoglobin (HbA1c) and adiponectin were also seen in Qsymia-treated patients compared to those receiving treatment with the individual components.
"The extended-release formulation of Qsymia is key to providing the greatest level of weight-loss efficacy while minimizing tolerability concerns," said Louis Aronne, MD, Professor of Clinical Medicine at Weill Cornell Medical College and Medical Director of Center for Weight Management and Metabolic Clinical Research at New York-Presbyterian/Weill Cornell Medical Center, and a lead investigator in the study. "For decades, phentermine has been a mainstay in the medical treatment of obesity, but when combined with topiramate in an extended-release formulation, we see greater weight loss, less heart rate increase and greater reduction in blood pressure."
Qsymia was designed to allow once-daily dosing, with phentermine immediate-release (IR) released in the morning and topiramate extended-release (ER) released in the evening. The delayed release of topiramate ER lowers the maximum observed plasma drug concentration by 29% and delays the time to maximum plasma concentration by seven hours. The study notes that this unique pharmacokinetic profile may be responsible for the improved efficacy and tolerability of the combination doses versus their monotherapy counterparts.
About the Study
|Authors:||Louis J. Aronne, Thomas A. Wadden, Craig Peterson, David Winslow, Sarah Odeh and Kishore M. Gadde|
|Title:||"Evaluation of Phentermine and Topiramate versus Phentermine/Topiramate Extended-Release in Obese Adults"|
(Dr. Aronne has received compensation from VIVUS for lectures, panel discussions and for serving on its national advisory board.)
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 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. 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, as amended by the Form 10-K/A filed on April 30, 2013 and by the Form 10-K/A filed on June 12, 2013, and periodic reports filed with the Securities and Exchange Commission.
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