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FDA To Review First of 3 New Weight Loss Drugs

By EscapeDummy, Jul 12, 2010 | | |
Tags:
  1. EscapeDummy
    [h1]FDA to review first of 3 new weight loss drugs[/h1]



    WASHINGTON – Dieters, doctors and investors get their first extensive look at the first of a trio of new weight loss drugs this week. The hope is that the new drugs can succeed where many others have failed: delivering significant weight loss without risky side effects.
    With U.S. obesity rates nearing 35 percent of the adult population, expectations are high for the first new prescription drug therapies to emerge in more than a decade. Even a modestly effective drug has blockbuster potential.


    None of the three medicines represents a breakthrough in research. Drugmakers have made little headway in understanding and treating the causes of overeating. Two of the drugs submitted for approval simply combine existing drugs — an anticonvulsant and an amphetamine — but have worrying side effects. The third, a new medication, is safer but less effective.


    The quest for a blockbuster weight loss drug has been plagued for decades by safety issues. The most notable was Wyeth's diet pill drug combination fen-phen, which was pulled off the market in 1997 due to links to heart valve damage and lung problems. The FDA is expected to post its review of Vivus Inc.'s pill Qnexa on Monday and will hold a public meeting Thursday to review the data. Orexigen Therapeutics Inc.'s Contrave is set for review in October, and Arena Pharmaceuticals Inc.'s lorcaserin is set for December.


    "There's no obvious clear winner," said Leerink Swann analyst Steve Yoo. "If you look at different aspects, each drug shines." To be considered effective, obesity drugs should reduce total body weight by at least 5 percent after one year, according to FDA guidance to companies. Qnexa showed the best weight loss results in clinical trials, with patients losing between 13 percent and 15 percent of their body weight. But the drug also had the highest rate of patient dropouts due to side effects, which include memory and concentration problems.
    Qnexa is a combination of two older drugs: the amphetamine phentermine and topiramate, an anticonvulsant drug sold by Johnson & Johnson as Topamax. According to the company, phentermine helps suppress appetite, while topiramate makes patients feel more satiated.
    Contrave is also a combination pill, mixing an antidepressant with an anticonvulsant drug. The drug has shown weight loss between 5 percent and 10 percent with side effects such as nausea.


    University of Liverpool Professor Jason Halford said drug companies are taking a multi-pronged approach to obesity therapies because science has shown there are multiple brain signals that drive food intake.
    "We're using combinations of old drugs with a very broad spectrum of pharmacotherapy, it's very much the shotgun approach," said Halford, a health psychologist who has consulted for drug companies on obesity treatments.


    The one truly novel drug under FDA review showed the weakest results in clinical trials. Arena Pharmaceuticals' lorcaserin is a first-of-a-kind drug that acts on serotonin, a brain chemical associated with feelings of well-being and satiation. But patients in company trials lost just 5 percent of their body weight.
    While Arena's drug trails its competitors in weight loss, it appears to have the least side effects, an important factor in FDA approval.
    Investors clearly favor Vivus in the three-way race. Shares of Vivus have nearly doubled over the past year to close Friday at $11.52.
    Arena Pharmaceuticals shares have fallen nearly 4 percent over the past year on lackluster results for its drug. Orexigen shares have fallen 21 percent over the past year, to close Friday at $4.17, marking a bouncy descent from a June 2007 peak of $17.70 a share.


    Decision Resources, a drug industry analysis firm, believes all three drugs could eventually win approval and find a place in the global obesity market. The firm expects the global market to soar from $500 million to $3.4 billion a year by 2018. Still, the history of diet drugs is littered with stumbling blocks. The diet drug fenfluramine, which was half of the fen-phen combination, was withdrawn in 1997 after it was linked with heart damage. The drug's combination with phentermine was popular but never approved by FDA.



    Two years ago Sanofi-Aventis SA discontinued studies of its highly anticipated pill Acomplia due to psychiatric side effects, including depression and suicidal thoughts. Side effects have kept the small number of weight-loss drugs currently on the market from being blockbuster sellers. Abbott Laboratories' appetite suppressant Meridia was pulled from the market in Europe last November due to data showing increased heart attack risks. And in May, the FDA warned consumers that the over-the-counter weight loss pill alli, which has been sold for years at a higher dose as the prescription drug Xenical, could cause severe liver damage. The drug works by limiting the amount of fat the body can absorb.



    Derek Lowe, a pharmaceutical researcher and blogger, says the new combination drugs under review hold promise because they work on multiple brain chemicals that drive overeating."No single agent is going to shut down this behavior," said Lowe, whose blog "In the Pipeline" focuses on drug development. "But if you can come in and hit two or more of these different pathways at the same time, maybe then you'll get somewhere."


    By MATTHEW PERRONE, AP Business Writer Matthew Perrone, Ap

    http://news.yahoo.com/s/ap/20100712/ap_on_he_me/us_obesity_drugs_fda




Comments

  1. shivakiva2112
    Why are all of the weight loss drugs psychoactive? pr0t0-man is sort of a health nut, and knows of much better ways of losing weight than taking any amphetamine-like compound. That's not a 'sustainable' way to lose weight, in their experience. Better to target the leptin system, and then do the usual controlled diet (high in EFA's, conjugated linoleic acid), fresh vegetables and fruits, and whole grains with lots of fiber, protein, and complex carbohydrates (Sara Lee wheat bread and quaker quick oats don't count).

    OH, and let's not bother to address the cause of the obesity epidemic either. Let's just take the typical American shotgun approach and throw some psychoactive drugs at the fat people's brains. That does not sound like a step up for public health, if you ask the pr0t0-man.
  2. missparkles
    I think the reason obesity is such a huge problem today is firstly the way we live, our instant grat society. "I'm hungry, and I'm hungry now" society. Years ago it took a couple of hours to prepare and cook a meal, so, as you didn't wanna spend all day in the kitchen, you had set meals that the whole family would eat, 3 times per day. Nowadays if you think you feel hungry (perhaps hungry enough that an apple or banana would be enough to get you through until the next mealtime) you pop out and choose from burgers, fried chicken, pizzas and massive meal sized sandwiches. And that is what is one of the main causes of the rise in obesity, in my opinion. Access to food is just too easy, no one is prepared to wait.

    The second reason is because of all the quick fixes, just like these pills that are soon gonna be available. You see keeping your weight within a specific range is all about educating your mind (and body). Eating healthy, non processed, fresh foods, and eating smaller portions. This, alongside making sure one gets plenty of exercise, is the only way to lose weight, and keep it that way. One of the common problems of weight loss pills is that when they're used, as soon as you quit taking them, your weight just steadily begins to increase.

    So, between people eating junk food they don't need, in portions that are unhealthy, and the quick fix diet pills, they learn nothing. Dieting shouldn't be a quick fix, a one off solution, it should be part of a healthy lifestyle. Where once the desired amount of weight is lost, it stays that way, by maintaining a healthier lifestyle.

    Just my 2 cents, for what it's worth?;)

    Sparkles.:vibes:
  3. toodarkpark
    So after reading this you would think that one of the others would have achieved approval first.???
    The lackluster results of lorcaserin must have impressed someone.
    My wife takes phentermine for weight loss, and she has had significant results in a short time. She is hoping that her diet and excersize changes coupled with the phentermine will boost her metabolism back to the way it was before. One thing is for sure, Americans need more healthy choices when hungry. Everything is junk these days. Even "fresh" means GMO. It's so hard for people who want to care to find good food. We find ourselves settling for junk due to lack of time(fabricated) and laziness. Taking a pill shouldn't be someones first, or only approach to weight loss, but at least it's "something" to combat the ever present cheeseburger the size of your head. ~peace
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