FDA approves new weight-loss drug

Sep 11, 2014
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FDA approves new weight-loss drug

Sep 11, 2014
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The Food and Drug Administration has approved a new weight-loss drug therapy. The drug, Contrave, is a combination of drugs used to treat depression (bupropion) and addiction (naltrexone). 

It’s approved for adults with a body mass index of 30 or higher (considered the threshold for obesity) and adults who are overweight (BMI of 27) but who also have a weight-related health condition.

In one trial cited by the FDA, 42 percent of patients treated with Contrave lost at least 5 percent of their body weight, while 17 percent of patients treated with a placebo did.

It has taken two attempts, four years, and several delays to get Contrave approved. In 2011, an FDA panel voted to approve the drug, but the agency declined and asked Orexigen, the drug’s maker, to pursue longer-term cardiovascular studies. When those studies were completed, the agency delayed approval again as it reviewed labeling and marketing requirements. 

“I don’t know what’s tougher, losing weight or getting an anti-obesity drug passed by the FDA,” says Robert Goldberg with the Center for Medicine in the Public Interest. Goldberg says obesity is linked to the central nervous system, and so are the drugs that treat it, so the FDA is extra-cautious. “The FDA is also worried that people will take these medicines and use them just to get an eight pack after their insanity workout,” when they are otherwise healthy. “Does it have a different bar? Absolutely.”

And yet, despite concerns about widespread use or abuse, sales of existing drugs on the market have proven disappointing. 

“The weight-loss drugs are not completely accepted as standard therapy, even for patients who are obese,” says Dan Mendelson, CEO of Avalere Health. He says getting doctors and patients comfortable with these drugs has proven difficult.

Another challenge for any weight-loss drug is how and whether insurance companies cover it. 

“If a drug is approved and not widely covered, it’s not gonna get adopted,” says Mendelson.

There are at least three more weight-loss drugs under development. 

 

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