After negotiating with the FDA over whether a cardiovascular trial had to be done pre or post approval, the FDA held out and Orexigen folded. Orexigen Therapeutics, Inc. – Press Release Evidently, the FDA wanted a trial of between 60.00 and 100,000 patients. Orexigen propsed a trial of between 12,000 and 15,000 patients. The FDA said no, of course. Orexigen Says FDA’s Requests for Contrave Trial Aren’t ‘Necessary or Feasible’ – Health Blog – WSJ
As indicated elsewhere (scroll down to September 10,2010), the FDA is in a bind. An obesity drug of moderate efficacy, they feel, is not worth any risk. While a drug with significant weight loss (read Qnexa) they fear will be used by so many people (since obesity is an epidemic, after all) that unforeseen adverse events will arise and they will have to take the drug off the market. Then there is the head of the FDA Drug Evaluation Center who wants to make drugs for weight loss into drugs for cholesterol or hypertension.( See What’s Up with the FDA, Part 2) Make no mistake, the FDA bureaucracy is more afraid of the embarrassment of withdrawing a drug from the market (see the Avandia discussions) than they are of the mortality and morbidity of obesity.
Interestingly, (ominiously??) , the Orexigen release indicates that the FDA will hold an advisory committee early next year on the cardiovascular aspects of obesity therapeutics. This could be the final nail in the coffin of obesity therapeutics.