Sanjay Kaul, who was a panel member and who voted against approval, provided the following comment to CardioBrief:
The drug does not yield a weight loss efficacy margin that allows an acceptable safety trade-off consideration, especially given the adverse blood pressure and heart rate signals. When you couple that with a selective low-risk patient population (which is arguably not representative of the intended use of the drug in the real world), and the short-term exposure, the benefit-risk assessment becomes even more challenging. The drug resembles sibutramine (meridia), both in terms of its modest efficacy and cardiometabolic profile and blood pressure and heart rate signals. Meridia was withdrawn from the US market based on the results of the SCOUT trial which revealed an increased cardiovascular risk.
In a followup note, Kaul made it clear that, despite the final vote, he believes the panel could hardly be said to have endorsed Contrave, suggesting that the road to approval may still contain a few rocks