It is becoming common practice for the Food and Drug Administration (FDA) to reject applications for new weight loss drugs. Over the past year, the FDA rejected applications for three anti-obesity medications. This week, the FDA rejected the application for Contrave. Contrave is a combination of an antidepressant and an anti-addiction drug to curb
appetite. Early studies demonstrate modest weight-loss benefits (i.e., approximately 4.5% weight loss).
However, FDA scientists
and safety advocates were critical of the data indicating Orexigen, Contrave's manufacturer, enrolled a limited number of elderly
patients or patients with a history of heart disease in its trials,
making it difficult to determine the drug’s safety in patients who are
likely to need it most.