Three Weight Loss Drugs Make 2nd Bid For Approval

The Food and Drug Administration has rejected three prescription diet pills in the last three years, raising questions of whether any weight loss drug can win approval in the U.S. The agency has not approved a new prescription weight loss drug in 13 years. Historically, medications that attempt to burn fat or suppress appetite have been plagued by safety issues.

Despite the latest rejections, all three drugmakers are resubmitting their products for a second review. Here's a look at the contenders and where they are in the review process:

— Qnexa is a combination of two older drugs: the amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an anti-convulsant drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite, while topiramate is believed to make patients feel more satiated

Many experts view the combination pill as the most promising of the new weight loss drugs, due to studies showing most patients lost nearly 10 percent of their weight — the highest reduction reported with any recent diet pill. But the FDA rejected the drug in October 2010, raising a number of safety concerns, including higher heart rate and birth defects in women who become pregnant.

This week a panel of advisers to the FDA overwhelmingly recommended approval for Qnexa, on the condition Vivus Inc. conduct a follow-up study to make sure the drug doesn't cause heart problems. The FDA is expected to make its second ruling on the drug by April 17.

— Orexigen Therapeutics Inc.'s Contrave is another combination pill aimed at curbing appetite, mixing the antidepressant ingredient in Wellbutrin with the anti-smoking drug bupropion. The company's results have been lackluster, with about 40 percent of patients taking Contrave losing 5 percent of their body weight. Those figures narrowly achieved FDA's minimum requirements for an effective weight loss pill. But Contrave has also been plagued by the heart safety concerns associated with past diet pills. The FDA is requiring the company to conduct a 10,000-patient study of cardiovascular health. That study is slated for completion by 2014.

— Arena Pharmaceutical Inc.'s lorcaserin is the only first-of-a-kind diet drug currently before the FDA. It uses a new type of ingredient to stimulate serotonin receptors in the brain linked with feelings of satiety. But lorcaserin has faced the most severe safety questions from FDA, which rejected the drug in 2010 after raising concerns about cancerous tumors seen in rats who received the drug.

Early this year Arena submitted new information evaluating the link between its drug and cancer. The FDA is scheduled to make a new ruling on the drug by June 27.

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  • by Pete Location: Grifton on Feb 26, 2012 at 06:33 PM
    Hit the gym and get for life 24 is a good choice in greenville.
  • by Anonymous on Feb 26, 2012 at 12:45 PM
    Before going on any diet yo may want to consult a doctor. I went on a diet only to find I had a medical problem. The diet could have had serious consequences had I not seen a doctor and discovered the medical issue. Make sure you are medically fit before doing anything.
    • reply
      by Anonymous on Feb 26, 2012 at 02:38 PM in reply to Anonymous
      It cost 2 months worth of grocerys just to see the doctor. And after they run a few thousand dollars worth of test, you won't be able to afford to eat.
  • by drugs on Feb 26, 2012 at 09:25 AM
    first of all, its not easy for everyone to lose weight and many desperate people fall prey to "quick fix" solutions. I can attest to that. second of all, drugs arent what you think they are. they are often tested by the same people who invested in them, so what do you think the results will be? dont trust anything that preys on your emotions! while its not as easy as it sounds, i agree with the posters that reduction in calorie intake and increase in exercise is the answer. for some people this requires outside help, and others can do this without help. either way, if youre working towards your health, theres no shame in getting help! good luck to anyone fighting this fight!
  • by Anonymous on Feb 26, 2012 at 05:46 AM
    "resubmitting their products for a second review" with much more cash under the table this time.
  • by Shine Location: NE NC on Feb 26, 2012 at 05:38 AM
    If you want to lose weight just stop eating at a drive thru. Low carbs and cut the sugar and combine it w/ exercise. You would be supprised what it will do. Invest in an exercise bike ==== My wife eats all of the cheese, nuts, beef jerkey, but has stayed away from the sweets (although she and myself bake alot of desert kinda of foods) we give it away - just b/c we love to bake. She can lose weight quick if she thinks she has gained some pounds.
    • reply
      by Anonymous on Feb 26, 2012 at 07:35 AM in reply to Shine
      This comment has been deleted.
      • reply
        by drugs on Feb 26, 2012 at 09:27 AM in reply to
        making yourself puke doesnt necessarily help you lose weight, ironically. it does damage the esophagus, stomach, teeth, and heart. while im thinking you are just being sarcastic, hopefully, self destructive behaviors only serve to vicious cycles--you can beat yourself into thin, until youve had enough and get fat again. healthy weight loss helps you stick to healthy habits for life.
      • reply
        by Anonymous on Feb 26, 2012 at 10:07 AM in reply to
    • reply
      by Anonymous on Feb 26, 2012 at 11:38 AM in reply to Shine
      So you take care of your own health by eating right and you poison your friends and neighbors with unhealthy baked goods instead. Special.
    • reply
      by thenewme on Feb 26, 2012 at 12:30 PM in reply to Shine
      so true, ive lost 100 pounds by watching my food intake and exercising 5 days a week. You can do it on your own and save lots of time and money!!! Its been a hard 7 months but I did it and you can too.
      • reply
        by US-First on Feb 26, 2012 at 06:54 PM in reply to thenewme
        Give us a break. 100 lbs in 7 months is nothing to be proud of unless you had gastric bypass surgery and initially weighted over 450lbs. There is no healthy way to lose 100 lbs in 7 months. I hate to say your rebound is going to hurt awfully bad.

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