ASBP concerned over FDA rejection of Contrave drug

Feb 8 2011

The American Society of Bariatric Physicians (ASBP) is concerned that the FDA recently rejected the weight-loss drug Contrave, contradicting the FDA advisory panel's recommendation for approval.  The rejection of Contrave marks the third weight-loss drug to be rejected by the FDA in the past six months.  The rejection leaves physicians with limited options to address the obesity epidemic, one of the nation's top public health issues.

ASBP's physicians treat obesity and obesity-related co-morbidities on a daily basis and believe the FDA's standards for approving anti-obesity drugs are overly stringent and fail to recognize the health risks associated with carrying extra weight. Current FDA guidelines suggest that for any weight-loss drug to be considered effective it must either  

1. reduce total body weight after one year by at least five percent more than the placebo group, or  
2. help at least 35 percent of patients lose at least five percent of their baseline body weight.

In the Phase 3 Clinical Trials, Contrave was shown to induce at least a five percent weight loss in more than 35 percent of patients.  Although Contrave met the benchmark for efficacy, the FDA based its rejection of Contrave on concerns of long-term use and heart problems.  

While ASBP understands and appreciates the cautious manner in which certain anti-obesity drugs are viewed, the FDA seems to lose sight of the many health risks associated with obesity. Obesity-related health risks include diabetes, heart disease, stroke, osteoarthritis, and several types of cancer, to name just a few.  There is ample evidence that obesity is a metabolic abnormality and that pharmacologic interventions can help with weight loss and maintenance, reversing or delaying the development of obesity-related health problems.

Furthermore, the ASBP finds it contradictory that the FDA advisory panel recently recommended lowering the BMI requirement for lap-band surgery without asking for further long-term outcome studies.  Meanwhile, the FDA rejected Contrave and requested the company conduct a study of sufficient size and duration to address the risk of heart attack and stroke. Unfortunately, such studies will likely be costly and require several years to complete, which means that significant time will pass before this drug comes up for approval again.  

The ASBP expects the FDA to consider the demonstrated effectiveness and benefits of weight-loss drugs even if those drugs may carry increased hypothetical risk, because a reduction in obesity leads to a multitude of beneficial effects, which far outweigh minor risks.