Contrave is latest weight-loss drug to be rejected by FDA

Contrave, a weight-loss drug that was given the green light by a Food and Drug Administration advisory panel last summer, has been rejected by the federal agency over concerns about long-term use and heart problems.

Drug-maker Orexigen Therapeutics issued a statement Tuesday saying it received a letter from the FDA that called for a long-term study of the drug that promised to help obese people lose 5% of their body weight in a year.

The statement describes the FDA action in part: “Specifically, the letter stated that “before your application can be approved, you must conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with naltrexone/bupropion does not adversely affect the drug’s benefit-risk profile.”

Contrave was designed to boost metabolism by combining two drugs -- the antidepressant bupropion with the anti-addiction drug naltrexone. Orexigen said it would work with the FDA to determine how to proceed in gaining approval of the drug. Here’s the company’s statement.

But Contrave isn’t the only weight-loss drug recently rejected by the FDA. This Los Angeles Times story explains why the prospect of anti-obesity drugs appears bleak. For example, Qnexa and Lorqess were rejected last year by the FDA, and Meridia was taken off the market in October after reports of it boosting the risk of heart attacks in strokes among people taking it.

It’s possible these actions might push drug companies to walk away from further development of anti-obesity drugs -- much to the chagrin of the growing number of Americans who struggle with obesity. Then again, considering the potential market, maybe drug companies will keep trying.