Silver Spring, MD – In its latest blow to obesity medication development efforts, the US Food and Drug Administration (FDA) yesterday notified Orexigen Therapeutics that it would need to conduct an extremely large-scale study of the long-term cardiovascular effects of its drug, Contrave, before approval could be considered. The economics of such a trial make it extremely unlikely that it can be done; effectively ending hopes for approval, despite the earlier recommendation of the FDA’s own advisory panel to approve the drug for use prior to a study.
This makes the third obesity medication that the FDA has disallowed in less than 12 months. The agency has not approved an obesity drug since 1999, and, last year, also removed from the market a drug it approved in 1997. News reports are already speculating that these actions will cause the pharmaceutical industry to avoid the field, stifling research on obesity medications for years to come.
More than a third of US adults are obese, and vulnerable to obesity’s damaging consequences. Obesity is responsible for the deaths of more than 100,000 Americans each year. Costs attributable to obesity and overweight have been estimated at $270 billion annually, including direct medical costs and indirect costs, such as absenteeism and productivity losses.
“In the face of such a devastating, widespread and expensive public health crisis as obesity, it is baffling that the FDA has consistently denied approval for anti-obesity medications," said Dr. Jennifer Lovejoy, President of The Obesity Society (TOS). “The FDA seems to expect that any obesity medication must be as free of side effects as tap water. This is an unrealistic standard and one to which medications for other diseases are not held. TOS will be working with several other professional societies in the coming weeks to meet with FDA and Congressional leaders and discuss improvements to the process of reviewing obesity medications.”
About TOS The Obesity Society is the leading scientific society dedicated to the study of obesity. Since 1982, The Obesity Society has been committed to encouraging research on the causes and treatment of obesity, and to keeping the medical community and public informed of new advances.