SOURCE: VIVUS, Inc.

VIVUS, Inc.

October 06, 2014 07:00 ET

Newly Published Data Highlight the Effects of Weight Loss With Qsymia in Type 2 Diabetes

MOUNTAIN VIEW, CA--(Marketwired - October 06, 2014) - VIVUS, Inc. (NASDAQ: VVUS) today announced the publication of a paper examining study results that demonstrate the positive impact of weight loss with Qsymia® (phentermine and topiramate extended-release) capsules CIV (PHEN/TPM ER) plus lifestyle modification on glycemic control in subjects with type 2 diabetes.

The paper was published online in the journal Diabetes Care.

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.

The authors examined results from two randomized, 56-week placebo-controlled clinical studies (phase 2 study, OB-202/DM-230, and a post hoc analysis of phase 3 CONQUER study) in overweight or obese patients with type 2 diabetes over a broad range of severity, treated with lifestyle modification and PHEN/TPM ER. The subset of patients with type 2 diabetes in CONQUER was treated with metformin or diet alone at study entry, while patients in OB-202/DM-230 had more longstanding diabetes that required more intensive therapy.

The study groups comprised 130 subjects with type 2 diabetes enrolled in OB-202/DM-230 (mean baseline HbA1c 8.7%) and 388 subjects with type 2 diabetes in CONQUER (mean baseline HbA1c 6.8%). At week 56 in OB-202/DM-230, change in weight (from intent-to-treat sample with last observation carried forward [ITT-LOCF]) was -2.7% for placebo and -9.4% for PHEN/TPM ER top dose (15/92 mg; P<0.0001 vs. placebo). Change in HbA1c level (ITT-LOCF) was -1.2% for placebo and -1.6% for PHEN/TPM ER top dose (P=0.0381). In both OB-202/DM-230 and CONQUER, greater numbers of patients randomized to receive PHEN/TPM ER treatment achieved the recommended HbA1c targets, with reduced need for diabetes medications when compared with the placebo group.

Common adverse events included paraesthesia, constipation, and insomnia.

"These data confirm the efficacy of medically-assisted weight loss in type 2 diabetes patients," said Timothy Garvey, MD, Chairman of the Department of Nutrition Sciences, University of Alabama at Birmingham, the lead author and an endocrinologist specializing in metabolic diseases. "The significant impact on cardiometabolic parameters observed in these studies, particularly with respect to HbA1c lowering, further proves that lifestyle modification combined with a weight loss medication such as PHEN/TPM ER can be considered integral to the treatment of obese and overweight patients with type 2 diabetes."

About the Study
Authors: W. Timothy Garvey, Donna H. Ryan, Nancy J.V. Bohannon, Robert F. Kushner, Miriam Rueger, Roman V. Dvorak, and Barbara Troupin
Title: "Weight-Loss Therapy in Type 2 Diabetes: Effects of Phentermine and Topiramate Extended-Release"
DOI: 10.2337/dc14-0930

About Qsymia
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 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.

About VIVUS
VIVUS is a biopharmaceutical company commercializing Qsymia® (phentermine and topiramate extended-release) capsules CIV for the treatment of obesity. 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 ended December 31, 2013 as filed on February 28, 2014 and as amended by the Form 10-K/A filed on April 30, 2014, and periodic reports filed with the Securities and Exchange Commission.

Contact Information