VIVUS : Qnexa® Phase 3 Data Published In Obesity Show 14.4% Average Weight Loss In Severely Obese Patients Completing One Year Of Treatment

Nov. 3, 2011 - Weight Loss Accompanied by Improvements in Cardio-Metabolic Risk Factors -

VIVUS, Inc. (NASDAQ: VVUS) announced that results from the 56-week EQUIP study were published in Obesity, the peer-reviewed journal of The Obesity Society. The EQUIP study evaluated the efficacy and safety of the investigational drug Qnexa in 1,267 severely obese (BMI >/= 35 kg/m2) patients across 91 sites in the US. In addition to average weight loss of 14.4% of initial body weight among those who completed the study at the top dose of Qnexa, severely obese patients had improvements in blood pressure, glucose, triglycerides and cholesterol. The results with Qnexa suggest the potential to effectively treat severely obese patients without surgery.

"Obesity is a serious medical condition that threatens the public health and reduces the quality and length of lives. Currently available treatments are limited and options are needed," said lead investigator Dr. David Allison, director of the Nutrition Obesity Research Center, University of Alabama at Birmingham. "In this population of severely obese patients, those taking Qnexa experienced significant weight loss and reduction in risk factors for many chronic diseases. The results refute a common notion that nonsurgical treatments are not effective for extremely obese persons. The findings are especially relevant to the 14% of the US adult population classified as extremely obese."

Patients in the study had a baseline body mass index of >/= 35 kg/m2, and an average initial weight of 256 pounds. Treatment was well tolerated, with no evidence of serious adverse events induced by treatment... VIVUS' Press Release -

VIVUS : Additional Data From QNEXA Clinical Trials Presented at the European Congress on Obesity

May 31, 2011 - Presentations to European Medical Community Highlight the Benefits of QNEXA Treatment Including:
- Prevention of Progression to Diabetes
- Sustained Weight Loss over Two Years, and
- Reduction in Cardiometabolic Risk

- VIVUS, Inc. (NASDAQ: VVUS) announced that multiple abstracts were presented over the weekend at the European Congress on Obesity (ECO) in Istanbul, Turkey. ECO is the official obesity congress of The European Association for the Study of Obesity (EASO). ECO is regularly attended by more than 2500 participants from over 75 countries and is considered to be the most important annual scientific event on obesity in Europe.

Highlights from the ECO presentations were as follows:

A poster presentation authored by W. Timothy Garvey, MD from the University of Alabama at Birmingham reported reductions in progression to type 2 diabetes and improvement in glycemic status in CONQUER patients that were ADA-defined as prediabetics at baseline. Of the 2,487 patients in the CONQUER study, 1,119 were determined to have prediabetes. In the prediabetics treated with QNEXA, hemoglobin A1c, fasting glucose and fasting insulin were significantly improved at week 56 (ITT-LOCF p<0.005 vs. placebo). In the prediabetic population significantly more QNEXA treated patients achieved normal blood sugar levels (p=0.0016) and significantly more patients on placebo were progressed to type 2 diabetics as compared to the QNEXA treated patients (p=0.0253).

"For this set of patients, QNEXA treatment led to benefits above and beyond losing weight. The results highlighted by Dr Garvey showed that weight loss after 56 weeks of treatment led to an improvement in glycemic status and reduction of progression to type 2 diabetes. This clinically important finding further strengthens the QNEXA benefit profile," added Barbara Troupin, MD, senior director of medical affairs for VIVUS.

The CONQUER study included 2,487 patients that had two or more comorbidities studied over 56 weeks. Patients were randomized to receive mid-dose QNEXA (498), top-dose QNEXA (995) or placebo (994). All patients received lifestyle modification instruction. QNEXA patients had significant weight loss at week 56 as compared to placebo (p<0.0001). Least squares mean percent weight loss at week 56 was 9.8% top-dose, 7.8% mid-dose, and 1.2% placebo. The most common side effects were dry mouth, tingling, constipation, upper respiratory infection and runny nose.

Dr Garvey also authored a poster that included the results of the SEQUEL study which showed that QNEXA treatment led to significantly greater weight loss as compared to placebo (p<0.0001, IIT-LOCF LS mean weight loss of 10.5% top-dose, 9.3% mid-dose, 1.8% placebo). The differences between both treatment groups and placebo were significant starting at week 8. Significantly more patients treated with QNEXA achieved greater than 5%, 10%, 15%, 20% weight loss in a dose-related fashion than placebo (p<0.0072). Specifically categorical weight loss over two years was as follows...VIVUS' Press Release -

VIVUS : Third Phase 3 CONQUER (OB-303) Trial

Apr 22, 2008 - VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, announced that it has completed enrollment in the final of three phase 3 studies of Qnexa(TM) in overweight and obese patients with co-morbidities including hypertension, dyslipidemia, or type 2 diabetes. The CONQUER study (OB-303) enrolled patients with a Body Mass Index ("BMI") ranging from 27 to 45 and at least two additional co-morbidities. The co-primary endpoints for this study are the mean percent weight loss and the percentage of subjects achieving weight loss of 5% or more... VIVUS' Press Release -

VIVUS : Enrollment in Phase 3 EQUIP (OB-302) Tria

March 27, 2008--VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, announced that it has completed enrollment in the first of two pivotal phase 3 studies of Qnexa(TM) in obese patients. The EQUIP study (OB-302) has enrolled over 1,250 morbidly obese patients with a Body Mass Index ("BMI") that equals or exceeds 35. The co-primary endpoints for these studies are the mean percent weight loss and the percentage of subjects achieving weight loss of 5% or more... VIVUS' Press Release -

VIVUS, Enrollment in EQUATE (OB-301) Trial completed

March 4, 2008--VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, announced that it has completed enrollment in the EQUATE study (OB-301). This trial, initiated in December 2007, will study the effects of Qnexa, an investigational drug, in obese patients with and without co-morbidities over 28 weeks. The EQUATE study has enrolled over 700 patients with Body Mass Index ("BMI") ranging from 30 to 45 in 35 clinical sites. The co-primary endpoints for these studies will evaluate the differences between treatments in mean percent weight loss and in the percentage of subjects achieving weight loss of 5% or more... Vivus' Press Release -

VIVUS, Qnexa Quality of Life Data

Oct. 22, 2007--VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, announced that Dr. Kishore Gadde presented the positive results of the Quality of Life data collected during the phase 2 clinical trial of Qnexa at the North America Association of the Study of Obesity (NAASO) 2007 Annual Scientific Meeting in New Orleans, LA... VIVUS' Press Release-