FDA Joint Panel Favors Approval of OTC Orlistat, But Long-Term Efficacy May Be Biggest Hurdle for Approval

On January 23, 2006, the FDA's Nonprescription Drugs and Endocrinologic & Metabolic Drugs committees considered the proposal for OTC orlistat. The joint advisory panel voted 11-3 in favor of approval; however, three issues of concern were raised: efficacy in patients who are only mildly overweight coupled with long-term efficacy; appropriate self-selection; and product safety. Although the panel felt that orlistat was safer when compared to current available OTC weight loss products, concerns were raised regarding significant drug interactions. Both cyclosporin and warfarin interact with orlistat with potential for severe negative consequences. Lack of patient understanding and studies of label comprehension indicate patients do not always read or comprehend labeling. Data presented at the joint advisory meeting showed that only 50% of patients taking warfarin correctly stated that they should not use orlistat. Also, only 35% of patients taking diabetes medications who viewed the labeling correctly identified the warning about adding orlistat to their regimen. The prescription NDA was conducted in patients who had a BMI of at least 28 and showed 42-25% of subjects achieving a 5% weight loss versus 23% using placebo. However, the OTC study reported the efficacy of orlistat in patients with a BMI of 25-28 resulting in a 5% weight loss in only 35% of treatment subjects versus 28% in those using placebo. In addition, there is no data to support that weight loss is maintained after the suggested six-month treatment period for OTC use. It is commonly accepted that once weight loss treatment is stopped, lost weight is quickly regained unless the patient has incorporated exercise and dietary modifications during weight loss and continues these after stopping drug therapy. In addition, the FDA has indicated that long-term usage and benefits are important considerations when approving drugs for chronic conditions. Using orlistat short-term (six months) has not been shown to provide any long-term clinical benefits such as reduced risk of serious disease. The panel was not concerned over the potential loss of fat-soluble vitamins because of the short-term six-month treatment period. For more information go to http://www.fdaadvisorycommittee.com Return to Top