Today, 64.5% of adult Americans are categorized as overweight or obese and nearly one-half of these (30.5%) - about 60 million Americans - are obese (BMI>30). According to the Center for Disease Control, about 32% of adult American women under 54 (about 25 million women) suffer from obesity ( BMI≥30) .Obesity significantly increases the risk of illness of about thirty serious medical conditions and is associated with increased deaths. Among these are high blood pressure, diabetes, heart disease, stroke, gallbladder disease and cancer of the breast, prostate and colon. Obesity has recently been recognized by the FDA as an epidemic and the need for pharmacological intervention is gaining widespread acceptance. Current drug therapy for obesity is dominated by three compounds; however, despite the huge need, annual sales are only around $1.1 billion, mainly due to their mediocre efficacy and problematic side effects, such as hypertension, gastrointestinal disturbance, psychiatric effects and abuse liability. There is a clear need for more efficacious and safer drugs to treat obesity, and the market for a safe and effective anti-obesity drug has been estimated at over $3 billion.

However, this has proven a very difficult objective. Weight and obesity management is regulated by a highly complex network of mechanisms which are difficult to circumvent, making this indication a very difficult one to combat. In fact, the only clinically significant weight loss evidence has been achieved by combination therapy targeting at least two of the control mechanisms.

Yet, among the multiple reasons for obesity, there are some which may be more easily delineated to one or two mechanisms, often due to a drug induced side effect. Foremost among these is obesity in psychiatric patients requiring antipsychotic drug treatment.