Navigation Links
Results From Phase 3 EQUATE Trial of VIVUS' Qnexa Highlighted at European Congress on Obesity
Date:5/7/2009

Study Results Demonstrated Significant Weight Loss in Obese Patients Treated with Qnexa

MOUNTAIN VIEW, Calif., May 7 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS), a biopharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced that data from the previously reported 28-week phase 3 EQUATE trial of Qnexa(TM) in obese patients are being presented today at the 17th annual European Congress on Obesity (ECO) in Amsterdam, The Netherlands. The results, titled "Weight Loss at 6 Months with VI-0521 Treatment," will be presented at the Hot Topic poster session by Donna H. Ryan, M.D., Associate Executive Director for Clinical Research, Pennington Biomedical Research Center in Baton Rouge, LA. The presentation marks the first time these results have been shared with the medical community at a major medical meeting.

The phase 3 EQUATE trial evaluated weight loss achieved with two doses of Qnexa versus that achieved with placebo among 756 patients over 28 weeks. Patients taking full-dose and mid-dose Qnexa achieved an average weight loss of 9.2 percent and 8.5 percent, respectively, as compared to 1.7 percent reported for the placebo group. All results were evaluated using ITT-LOCF, the method of analysis required by the U.S. Food and Drug Administration.

"Obesity has reached epidemic proportions, affecting more than 300 million people worldwide and contributing to increased prevalence of life-threatening illnesses such as hypertension, diabetes, cardiovascular disease and stroke. Patients are in urgent need of new, safe and effective tools to help them achieve the weight loss critical to their health and wellbeing," said Dr. Ryan. "The weight loss seen in patients taking Qnexa, over just 28 weeks, is encouraging for those of us in the medical community treating patients who have struggled unsuccessfully to lose weight for years."

The proportion of Qnexa patients losing 5 percent or more of their initial body weight was 66 percent for full-dose, 62 percent for mid-dose and 15 percent for placebo. The proportion of Qnexa patients losing 10 percent or more of their initial body weight was 41 percent for full-dose, 39 percent for mid-dose and 7 percent for placebo.

Qnexa was well-tolerated, with no drug-related serious adverse events in the study. The most common adverse events reported for the full-dose, mid-dose and placebo group were tingling (23%, 16%, 3%), dry mouth (18%, 13%, 0%), headache (16%, 15%, 13%), and constipation (15%, 7%, 8%). The completion rate for the study overall was 70 percent.

"The weight loss seen across our phase 2 and phase 3 obesity and diabetes Qnexa trials to date, coupled with the positive impact observed on other cardiometabolic factors such as blood pressure, cholesterol and glucose, is impressive and potentially represents a step forward in the treatment of obesity and obesity-related conditions," commented Leland Wilson, president and chief executive officer of VIVUS. "We are delighted to see these data - the first of our three phase 3 clinical trials evaluating Qnexa for obesity - highlighted at ECO."

In addition to EQUATE, the phase 3 Qnexa program includes two double-blind, placebo-controlled, multi-center studies that will compare Qnexa to placebo during a 56-week treatment period. The first year-long study, known as EQUIP (OB-302), enrolled morbidly obese patients with a Body Mass Index (BMI) of 35 or greater. The second year-long trial, known as CONQUER (OB-303), enrolled overweight and obese adult patients with BMIs from 27 to 45 and at least two co-morbid conditions, such as hypertension, dyslipidemia and type 2 diabetes. The co-primary endpoints for these studies are the mean percent weight loss and the percentage of subjects achieving a weight loss of five percent or more. In total, the phase 3 program has enrolled approximately 4,500 patients.

Results from these studies are expected in the third quarter of 2009.

About EQUATE

The EQUATE study included 756 obese patients (599 females and 157 males) across 32 centers in the United States. The average baseline BMI of the study population was 36.3 kg/m2 and baseline weight was 101.3 kg. The study was a randomized, double-blind, placebo-controlled, prospective trial with subjects randomized to receive once-a-day treatment with mid-dose Qnexa (7.5 mg phentermine/46 mg topiramate CR), full-dose Qnexa (15 mg phentermine/92 mg topiramate CR), the respective phentermine and controlled-release topiramate constituents, or placebo. Patients had a four-week dose titration period followed by 24 weeks of treatment. Subjects were asked to follow a hypocaloric diet representing a 500-calorie/day deficit and advised to implement a simple lifestyle modification program.

About Obesity

More than 300 million people worldwide and approximately 30 percent of American adults (more than 60 million people) are obese, a chronic condition defined by having excess body fat. As the second leading cause of preventable death, obesity directly contributes to numerous life-threatening conditions including diabetes, cardiovascular disease, hypertension and stroke. Experts agree that even a modest weight loss of five percent of weight, maintained over time, can bring significant health benefits by lowering blood pressure and reducing the risk of diabetes and heart disease.

About Qnexa(TM)

Qnexa (Q-NEX-uh) is a proprietary, low dose, controlled release formulation of phentermine and topiramate that simultaneously addresses both appetite and satiety - the two main mechanisms that impact eating behavior - in one daily capsule. Qnexa, an investigational drug, is an obesity therapy being developed to address type 2 diabetes as well as weight loss. In phase 2 and phase 3 clinical trials to date, Qnexa has demonstrated significant weight loss, glycemic control, and improvement in cardiovascular risk factors. Qnexa is well tolerated, with no drug-related serious adverse events reported to date.

About VIVUS

VIVUS is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health. The company's lead investigational product in clinical development, Qnexa(TM), is expected to complete phase 3 clinical trials for the treatment of obesity in 2009. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes. In the area of sexual health, VIVUS is in phase 3 development with avanafil, its PDE5 inhibitor drug candidate, and in phase 2 development of Luramist(TM), its drug candidate for the treatment of hypoactive sexual desire disorder (HSDD) in women. MUSE(R) (alprostadil), a first generation therapy for the treatment of ED, is already on the market and generating revenue for VIVUS. For more information about the company, please visit www.vivus.com.


'/>"/>
SOURCE VIVUS, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Boston Scientific Welcomes Publication of HORIZONS AMI Trial Results in New England Journal of Medicine
2. Poniard Pharmaceuticals Reports First Quarter 2009 Financial Results and Provides a Corporate Update
3. Transcept Pharmaceuticals to Report First Quarter 2009 Results
4. Perceptive Informatics Survey Results Reveal Top Barriers to Implementing Adaptive Trial Designs
5. Pharmaxis Announces Positive Results of Phase 3 Cystic Fibrosis Trial
6. Fovea Reports Positive Results with Prednisporin(TM) in Persistent Allergic Conjunctivitis
7. Study Results Present Paradigm Shift; REDUCE Trial Shows New Hope for the Risk Reduction of Prostate Cancer
8. Stallergenes S.A.: Positive Results From a Phase IIb/III Clinical Trial on the House Dust Mite Desensitization Tablet
9. Merz Pharmaceuticals Announces Results of Three Clinical Trials With NT-201 (Botulinum Neurotoxin Type A Free From Complexing Proteins) in Movement Disorder Patients
10. Lexicon Pharmaceuticals Provides Clinical Pipeline Update and Reports 2009 First Quarter Results
11. Human Genome Sciences Reports Positive Late-Breaker Results at EASL from ACHIEVE Phase 3 Trials of Albuferon(R) in Patients with Chronic Hepatitis C
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/8/2017)... 8, 2017   Responding to Heath Ledger,s ... death of singer Chris Cornell in May, the ... offers a free online psychiatric drug side ... families about psychotropic drug risks. The father ... from an accidental overdose, has called for tighter rules on ...
(Date:6/7/2017)... Specialty Infusion Group, a brand of Diplomat Pharmacy, Inc. (NYSE: DPLO), ... location. The Iowa ... 7 cleanroom—the standard needed to compound intravenous (IV) nutrition formulations. A ... "Our new cleanroom will allow ... Iowa patients," said Phil Rielly , ...
(Date:6/2/2017)... , June 2, 2017  NxStage Medical, Inc. (Nasdaq:  NXTM), a ... today announced new findings demonstrating positive biochemical outcomes related ... System One™. The data will be presented at the ... Madrid, Spain . The ... Home Dialysis Network in Europe ...
Breaking Medicine Technology:
(Date:6/23/2017)... , ... June 23, 2017 , ... Goodcents Deli Fresh ... The restaurant is located at 4210 SW 21st St. Topeka, Kan. 66604 (near 21st ... of Graham Restaurant Group who owns three other locations in the Topeka and Bonner ...
(Date:6/23/2017)... ... June 23, 2017 , ... Georgia State ... 18 to 20. , The two-day conference is focused on advancing scientific knowledge ... improving patients’ lives and eliminating racial breast cancer-related disparities. The conference theme is ...
(Date:6/23/2017)... CA (PRWEB) , ... June 23, 2017 , ... PureLife ... the endorsed amalgam separator supplier for CDA members. As part of the amalgam separator ... price of $99, saving more than $400 off the retail value. This partnership between ...
(Date:6/23/2017)... ... June 23, 2017 , ... Ulster University, Magee Campus in Northern Ireland ... to 3 pm to present to graduate students exciting new and innovative hope research ... project led by The Health Improvement Service of the Western Health & Social Care ...
(Date:6/23/2017)... ... 2017 , ... All-Star Insurance, a family managed agency that offers insurance management ... announcing the launch of a new charity drive to benefit women in the area ... reveal that an estimated 252, 710 new cases of invasive or high risk breast ...
Breaking Medicine News(10 mins):