FDA rejects another obesity drug
February 1st, 2011
12:41 PM ET

FDA rejects another obesity drug

Another weight-loss drug  brought to the U.S. Food and Drug Administration for approval has been rejected.

In the last 12 months, the FDA has nixed three new weight-loss drugs, lorcaserin because of possible links to cancer, Qnexa and now Contrave because of possible heart problems.

In December, an advisory committee for the FDA first voted  in favor of Contrave, a weight-loss drug that combines naltrexone and bupropion. That committee also voted  11 to 8 that the company, Orexigen should examine the drug's risk for major adverse cardiac events.

But, the FDA does not always follow the advisory committee's suggestions.  The agency rejected Contrave because of concerns about the cardiovascular safety after long-term use.

In a letter, the FDA told Orexigen, the company which created Contrave that it 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."

Michael Narachi, Orexigen’s president and CEO, said in a press release that they were “surprised and extremely disappointed” and said: "We plan to work closely with the agency to gain more information to determine the appropriate next steps regarding the Contrave application."

Contrave contains naltrexone, used to treat alcohol and cocaine addiction, and bupropion, an antidepressant, which also helps people quit smoking.

Contrave would’ve been used by patients whose initial body mass index is greater than 30 (obese) or 27 and greater (overweight) with one or more health risk factors such as diabetes or hypertension.  For an example, a man who is 5 feet and 10 inches and weighs 210 pounds would have a BMI of 30 and could be eligible to take the drug.

In the clinical trials, subjects who took the drug had modest weight loss - at least 5 percent of their body weight.

The subjects also had a small increase in blood pressure and pulse rate compared with the placebo group, and the “hypertension-related adverse events was significantly higher” in the drug group compared with the placebo subjects.

Read more from the FDA.

This is the last of the weight-loss drugs reviewed by the FDA in 2010, which have all seen uphill battles.

Last year, an advisory committee rejected Qnexa, citing concerns ranging from heart issues to psychiatric side effects. Another drug, lorcaserin was rejected after questions about the drug’s effectiveness and tumor development in rat studies.  A previously approved drug, Meridia made by Abbott Laboratories was voluntarily withdrawn from the market in October due to an increased risk for heart attack and stroke.

soundoff (9 Responses)
  1. Anon

    Drugs are not the answer to solve obesity in America.

    Why can't we Americans do something simple as eat less and exercise more? Oh, that's right because we are a lazy society looking for easy solutions, and not willing to work hard like the rest of the world, exactly why China and India will surpass USA as #1 and #2 world powers respectively.

    February 1, 2011 at 16:25 | Report abuse | Reply
  2. mjtrout14

    Not only do unhealthy lifestyles and overweight/obesity lead to health conditions such as Type II diabetes and a range of different hypertension and heart disease, but now a diet pill that may potentially cause additional cardiac problems? I understand that maintaining a healthy lifestyle by exercise and monitoring diets is not always easy, but these pills are not the easy way out that consumers anticipate either. The recommended amount of physical activity, which does not necessarily mean vigorously running or exercising to the point of pain, is only 60 minutes/day. Rather than turning to unhealthy diet pills or other supposed easy-outs is not the way to get that body or weight you want! With a combination of physical activity and nutritional food choices, these unhealthy drugs can be eliminated!

    February 1, 2011 at 16:29 | Report abuse | Reply
  3. Sandi

    Hopefully the FDA keeps rejecting these unnecessary obesity pills. This is a good move because it gives Americans fewer "easy way out" options

    February 1, 2011 at 17:01 | Report abuse | Reply
  4. foley

    People stop it with the "exercise more and eat less". So many of us "FATTIES" do just that and the weight does not come off! I am one of them! Probably healther than most "thin" people I know. It's not just about the things thin people say "you should do". I'm just say'in. . . .

    February 1, 2011 at 17:46 | Report abuse | Reply
  5. NYRunnerGirl

    As a recovering "fattie" (not to goal yet, but getting there) I agree that pills are not the answer. There are folks who have conditions that make weight loss harder for them, I agree. But many people, myself included, just simply overate and didn't exercise. There is no "magic bullet". It was easy to put the weight on; it is HARD work to get it off. But it can be done. It is something I will work on for the rest of my life.

    February 1, 2011 at 18:22 | Report abuse | Reply
  6. Adriana

    Congratulations to those of you who are able to exercise and eat a sensible diet and lose weight. But, these pills are not for this portion of the population. Medications are designed for people who have other issues that interfere with them losing weight that way. Maybe your weight gain is medication driven and hard to lose. Maybe you're disabled and can't do 60 minutes of aerobic activity, making weight loss more difficult. Maybe you have a heart condition and desperately need to lose weight, but hard activity isn't an option. Medications are for these people, who may be ill, obese, and can't just walk it off. Good medications on the market would save lives and money from difficult and painful operations. So, don't focus on what YOU can do, learn some EMPATHY!

    February 3, 2011 at 18:10 | Report abuse | Reply
  7. elizabeth

    I take naltrexone to control alcohol cravings thanks to an open minded addiction specialist md. I was not overweight at all but I still lost about 8 lbs from my starting weight of 135. It just makes you not hungry. No other effects at all. It blocks the high you get from consuming sugars and fats so you no longer think crave them. I have often wondered why more people can't be given this medication. Helps with alcohol cravings too.

    February 4, 2011 at 12:54 | Report abuse | Reply
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    I got my order in on time (last night, just a few hours before the dandliee), and I see my name is already on the credits page. According to the confirmation email I received, this will be shipped out within 1 week. So I guess I should expect to have this by the first March? 😉

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