MOUNTAIN VIEW, Calif., April 11, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that detailed results from the 56-week CONQUER study were published in The Lancet evaluating the efficacy and safety of investigational drug QNEXA in 2,487 patients across 93 sites in the US. Data published in the peer-reviewed journal provided an in-depth look at weight loss and improvements in the full spectrum of co-morbidities studied as secondary endpoints, including cardiovascular, metabolic and inflammatory risk factors.
"Obesity is a serious medical condition associated with increased mortality from cardiovascular diseases, diabetes, cancer and other diseases, yet there is a lack of treatment options for the one-third of American adults who are obese," said Kishore Gadde, MD, director of obesity clinical trials at Duke University and lead investigator. "Half the patients in the study had at least three co-morbidities including diabetes, representing a population with the greatest medical need for weight loss. We observed significant weight loss, improvements in co-morbidities and a reduction in the need for concomitant medications in patients treated with QNEXA."
Specific results for all patients through 56 weeks as published in The Lancet are as follows:
21%7%*p<0.0001 vs placeboBlood Pressure
More patients completed one year of treatment in the QNEXA groups, mid dose (69%) and top dose (64%) respectively, as compared to 57% in the placebo group. QNEXA therapy was well tolerated, with no unexpected adverse events. The most common side effects were dry mouth, paresthesia (tingling), constipation, insomnia, dizziness and dysgeusia (altered taste). Rates of serious adverse events were similar across treatment groups: 4% with placebo, 3% with mid-dose QNEXA and 5% with top-dose QNEXA. Most adverse events were seen early in treatment and there was a low dropout rate due to adverse events, 12% and 19% for mid and top dose respectively, compared to 9% for placebo.
About the CONQUER StudyThe CONQUER study included 2,487 overweight and obese patients (1,737 females and 750 males) with high blood pressure, high cholesterol or type 2 diabetes across 93 centers in the United States. The average baseline BMI of the study population was 36.6 kg/m2 and baseline weight was 227 pounds. The study was a randomized, double-blind, placebo-controlled, 3-arm, prospective trial with patients randomized to receive once-a-day treatment with mid-dose QNEXA, top dose QNEXA or placebo. Patients had a 4-week dose titration period followed by 52 weeks of treatment. Throughout the 56-week treatment period, all patients were advised to follow a modest lifestyle modification program including reduction of food intake by 500 calories per day. Patients were actively managed to standard of care for weight-related co-morbidities, which included the ability for physicians to adjust or alter medications for these conditions, including in the placebo group.
About QNEXA Controlled-Release CapsulesQNEXA [kyoo-nek-suh] is an investigational drug candidate being developed to address weight loss, type 2 diabetes and obstructive sleep apnea. QNEXA is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine and topiramate, which is designed to decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impact eating behavior. In phase 2 and 3 clinical data to date, patients taking QNEXA have demonstrated statistically significant weight loss, glycemic control, and improvement in cardiovascular risk factors, when used in combination with a diet and lifestyle modification program.
About VIVUSVIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead product in clinical development, QNEXA, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. QNEXA is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction. For more information about the company, please visit www.vivus.com
|SOURCE VIVUS, Inc.|
Copyright©2010 PR Newswire.
All rights reserved