Obesity   

The prevalence of obesity continues to be a health concern that affects a large and growing proportion of the population, including more than one third (more than 72 million) of American adults. Worldwide more than 400 million people are obese. Obesity directly contributes to numerous life-threatening conditions: diabetes, cardiovascular disease, hypertension and stroke and is the 2nd leading cause of preventable death in the U.S.

Beyond its impact on health, obesity economically accounts for 9.1% of U.S. annual health care spending - nearly $150 billion dollars. By 2030, if trends in the escalating rates of obesity continue, health care costs attributable to obesity may reach $956 billion, accounting for up to 18% of total health care costs, or $1 in every $6 spent on health care.

Qnexa® is an investigational, once a day, proprietary, oral, controlled-release formulation of low dose phentermine and topiramate, which is believed to address both appetite and satiety - the two main mechanisms that impact eating behavior

Phentermine was approved in 1959 and is currently indicated as short term treatment for weight reduction as an adjunct to exercise, behavior modification and caloric restriction.  Phentermine is currently the most widely prescribed weight loss therapy in the U.S.  Topiramate was first approved in 1996 as a treatment for epilepsy and more recently as a prophylactic for migraine.

Three pivotal phase 3 trials evaluating Qnexa in over 4,500 patients as a treatment for obesity were recently completed under a Special Protocol Assessment by the U.S. FDA. Qnexa is currently under review by the FDA for the treatment of obesity and is not approved.

EQUATE, the first of the three phase 3 studies, evaluated 756 obese patients over 28 weeks at 32 sites.  EQUIP and CONQUER were 56-week studies; EQUIP evaluated 1,267 morbidly obese patients with or without co-morbidities and CONQUER evaluated 2,487 overweight and obese patients with at least two co-morbid condition.

ITT-LOCF: Intent-to-treat with last observation carried forward
Clinical data from phase 3 trials demonstrated that Qnexa:

For full details please see the September 2009 press release and December 2008 press release.

Additionally, in December 2008, VIVUS announced an extension study to OB-303. This study will roll-over approximately 650 patients in a blinded fashion from OB-303, in order to provide two-year safety data.