Obesity has been linked to cancer, heart disease, high blood pressure, diabetes, and stroke. As a common underlying factor in so many preventable diseases, it’s no wonder that there is a huge potential market for anti-obesity drugs. Of course, exercise and diet might be the preferred prescription of many healthcare providers, but the option of a pill to ensure weight loss could improve public health. The FDA’s recent actions have been pushing drug development costs up to levels that have frustrated or stymied pharmaceutical company efforts to develop drugs to reduce the incidence of obesity.
Three companies have run the FDA’s gauntlet with their obesity drugs of late, without much to show for their more than $830 million invested1. Arena Pharmaceuticals took their drug, Lorqess, through Phase III clinical trials with good results. It was tested in almost 9000 patients at a cost of more than $400 million, only to be turned back by the FDA because they had disproven a negative: that their drug would not cause heart-valve disease1.
Orexigen’s Contrave is another example of an obesity drug that failed in Phase III clinical trials when the FDA requested a long-term heart attack study. Such a studies drive drug development costs even higher; the company had already invested more than $200 million in Phase III clinical trials. Additional trials could cost over $100 million1.
The only potential success story is Vivus’s weight-loss drug Qsymia, the first to make it to market in a decade. Its approval came after the Senate Appropriations Committee pressed on the FDA to bring more options to bear against America’s battle with obesity. Nudging the FDA from the outside might be what’s needed to increase the number of drugs on the market, and to encourage Pharma to keep developing.
If Orexigen and Arena can tolerate the drug development costs involved in more trials, they may yet get approved. But will they want to take the chance? In spite of so much need, Qsymia hasn’t had blockbuster sales2. Time will tell if pharmaceutical companies find the reward worth risky high drug development costs in the fight against obesity.
- A.S.A. Roy. Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials. Manhattan Institute for Policy Research. April 2012.
- T. Staton. Faced with flat sales, Vivus offers free trial on Qsymia weight loss drug. FiercePharma. Nov 26, 2012.