Results From Phase 3 EQUATE Trial of VIVUS' Qnexa Highlighted at European Congress on Obesity
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.
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.
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.
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.
CONTACT: Timothy E. Morris, Chief Financial Officer, VIVUS, Inc.,
+1-650-934-5200; or Investor Relations: Brian Korb, The Trout Group,
+1-646-378-2923; or Media Relations: Sheryl Seapy, Pure Communications, Inc.,
Web Site: http://www.vivus.com/
Posted: May 2009