CONTRAVE – post Advisory Committee, pre-PDUFA Date

We are post FDA Advisory Committee for the CONTRAVE (OREX) application which is seeking approval for use in the treatment of obesity but we are still awaiting the decision that counts – the action of the FDA on the application.

Many of us are still trying to come to grips with the Advisory Committee vote which recommended approval for this drug. It had only marginally better efficacy data than the other obesity drugs that were presented to this committee earlier this year but still had some cardiovascular problems and other safety issues that seem to tilt the benefit risk meter to the “too much risk” side. When you take into consideration that one of the alternative treatments is diet and exercise, the benefit risk meter goes off the scale with the risk clearly “outweighing” the benefit. Granted, obesity is a problem but is approving this fixed drug combination the solution? The data clearly show that this fixed combination of naltrexone and bupropion is not the magic bullet for clinically meaningful weight loss – it has side effects.

The bottom line is that there is still no reason to believe this fixed combination will gain approval. If the medical community believes there is merit in this combination, they are free to prescribe it as both drugs are available as generic single entity products.