Vivus Presents Qnexa For Obesity Treatment
The new drug Qnexa for the treatment of obesity and weight loss shows promise. Qnexa is a proprietary therapeutic formulation and dosing regime that incorporates the active ingredients from two previously approved products with demonstrated weight loss properties. By combining the activity of each of these compounds, Qnexa simultaneously addresses appetite and satiety, the two main mechanisms that impact eating behavior. As such, Qnexa appears to induce significantly greater weight loss than either individual compound. Further, clinical trials conducted with Qnexa have demonstrated superior efficacy and a significantly improved adverse effect profile as compared to other therapeutic options.
VIVUS and Duke University conducted a 200-patient, double-blind, placebo controlled Phase 2 trial designed to examine the safety and efficacy of Qnexa. Findings from this study demonstrated:
* Qnexa achieved significantly greater weight loss as compared to placebo and each of the product's active ingredients alone
* Qnexa achieved a placebo-adjusted weight loss of 20.1 pounds at week 24
o This is nearly twice the weight loss achieved with a high dose of Sanofi-Aventis' Acomplia (rimonabant) at week 52 (10.6 pounds) in a similar group of patients
* Weight loss with Qnexa had not plateaued at 24 weeks as has been observed with other obesity therapeutics in development
* Only one patient dropped out of the Qnexa study arm due to side effects (2%) wih only 8% total non-completers for any reason. Dropouts for topiramate alone were 14%, phentermine alone 24%, and placebo 38%, indicating how well Qnexa was tolerated in this population.
VIVUS is currently undertaking additional formulation development for Qnexa to increase the convenience of patient dosing. Ultimately, the final Qnexa formulation will offer once-a-day, oral dosing utilizing advanced sustained and controlled release technology which will provide precision release of each active ingredient in order to maximize efficacy and tolerability.
OBESITY: THE FACTS
More than 30% of American adults (more than 60 million people) are obese
Obesity directly contributes to numerous life-threatening conditions: diabetes, cardiovascular disease, hypertension, stroke and cancer
According to The Surgeon General's Call to Action to Prevent and Decrease Overweight and Obesity, the cost of obesity in the U.S. in 2000 was more than $117 billion
With obesity at epidemic levels in the United States, there is a critical need for effective and safe therapeutics to assist individuals in losing weight and improving their overall health. To date, most obesity treatments on the market and currently in development have demonstrated limited efficacy and considerable side effects, creating a significant need in this important medical sector. In response to this need, VIVUS is advancing a proprietary obesity therapeutic, Qnexa™. In a recent clinical trial conducted at Duke University, Qnexa demonstrated nearly double the weight loss in less than half the time as compared to the leading obesity drug in development. Clinical data also indicates that Qnexa may potentially offer a significantly improved side effect profile as compared to other therapeutic options.
OBESITY: THE MARKET
The world wide obesity therapeutic market is currently estimated to be approximately $1 billion
Analysts estimate that the markets for new obesity therapeutics Acomplia and APD356 are also $1 billion
Analysts speculate that the total potential obesity drug market is between $5 billion and $10 billion annually
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