Forums » Open clinical » Diabetes » Good News: FDA advisors recommend approval of Anti-Obesity drug, Qnexa.
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Good News: FDA advisors recommend approval of Anti-Obesity drug, Qnexa.
posted at 22/2/2012 10:14 PM GMT
on bmj.com
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Posts: 366
First: 13/4/2011 Last: 16/5/2012 |
Hello Fellows: This is the most potent Pill against Obesity and Obesity-Related Diabetes! Now it is legal!!! Silver Spring, MD - The Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee [1,2] voted overwhelmingly in favor of approving the obesity drug Qnexa (Vivus, Mountain View, CA), a combination of phentermine and controlled-release topiramate. Specifically, the panel voted 20 to 2 in favor of approving Qnexa, stating that the risk/benefit ratio is appropriate in patients with a body-mass index (BMI) of >30 kg/m2 or >27 kg/m2 in patients with weight-related comorbidities. Despite some concerns over increases in heart rate, in the range of 1 to 2 beats per minute, as well as concerns about potential birth defects in babies born to women taking the drug, particularly risks of cleft lip with or without palate, the panel felt the risks of untreated obesity outweighed these concerns. The panel strongly recommended the initiation and completion of a large morbidity and mortality study to address any potential cardiovascular risks, as well as the use of a risk evaluation and mitigation strategy (REMS) to accompany approval. This isn't the first time Qnexa has come before the advisory committee. In July 2010, the panel voted against the approval of the drug because of concerns about its safety, and this led the FDA to reject it. At the time, most panelists agreed the drug was effective at promoting weight loss but were disconcerted by the number of adverse events linked to the drug, including cognitive disorders, metabolic acidosis, increased heart rate, and birth defects. If the FDA ends up following the advice of its advisors, Qnexa could be the first prescription drug for obesity to reach the market since 1999.
All Best,
Joey |
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Re: Good News: FDA advisors recommend approval of Anti-Obesity drug, Qnexa.
posted at 23/2/2012 1:56 PM GMT
on bmj.com
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Posts: 142
First: 29/4/2011 Last: 14/5/2012 |
I hope that you are right Joey, but Johnson and Johnson has been trying for years to find a topiramate formulation that balanced weight loss and side effects; they have finally given up (http://docnews.diabetesjournals.org/content/2/1/5.full). I too well remember the Phen-fen fiasco. My suggestion is that we follow religiously the FDA panel's recomendations as to which patients are appropriate for this combination. However, both physicians and patients are desperate to find a solution to obesity and this combination, properly incorporated into a comprehensive weight loss strategy is certainly promising. |
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Re: Good News: FDA advisors recommend approval of Anti-Obesity drug, Qnexa.
posted at 26/2/2012 1:54 PM GMT
on bmj.com
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Posts: 366
First: 13/4/2011 Last: 16/5/2012 |
Thank you Dr. Diabetes: I see a lot of "off-label" prescriptions of Topiramate and only very few cases of Metabolic acidosis. I did not see any single report of cardiac valvulopathy induced by Phentermine. The data untill now are quite impressive with this Pill: "Qnexa". And you are right, let´s follow by the book the FDA recommendations. All Best, Joey
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Re: Good News: FDA advisors recommend approval of Anti-Obesity drug, Qnexa.
posted at 26/2/2012 3:26 PM GMT
on bmj.com
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Posts: 376
First: 15/7/2011 Last: 15/5/2012 |
Hi Joey,Does this mean that you will be able to prescribe this drug for your patients? Would it be effective in all cases of obesity and how does it actually work? Hopefully it will be a really effective medication to reduce obesity. Regards, Kirked |
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Re: Good News: FDA advisors recommend approval of Anti-Obesity drug, Qnexa.
posted at 26/2/2012 9:21 PM GMT
on bmj.com
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Posts: 275
First: 13/4/2010 Last: 15/5/2012 |
"However, both physicians and patients are desperate to find a solution to obesity" It's called calorie reduction and exercise. I personally no longer trust drug companies with there "too good to be true" pronouncements because, as always in life, when it sounds too good to be true it usually is. The history of medicine is littered with disastrous and dangerous "diet pills" so, for now, I will keep my counsel on this one until I have seen for myself incontrovertable evidence from independent, randomised, double-blind controlled trials. To quote from an ABC News story: "This is far from a great drug," said Dr. David Katz, director of the Yale Prevention Research Center. "The FDA panel recommended approval of Qnexa only because the ranks of useful weight loss drugs are so thin, and desperate times call for desperate measures. Approval of Qnexa would reflect that...desperation." |
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Re: Good News: FDA advisors recommend approval of Anti-Obesity drug, Qnexa.
posted at 26/2/2012 11:23 PM GMT
on bmj.com
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Posts: 366
First: 13/4/2011 Last: 16/5/2012 |
Hello Kirked and all other Fellows: My opinion is clear as that: In the actual context of the Obesity Global Epidemics, this pill deserves a fair chance to find its own place in Obesity and Obesity-Related complications like diabetes. I am deeply rooting for it!!! All Best, Joey
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Re: Good News: FDA advisors recommend approval of Anti-Obesity drug, Qnexa.
posted at 27/2/2012 11:11 AM GMT
on bmj.com
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Posts: 366
First: 13/4/2011 Last: 16/5/2012 |
Dear Fellows: "Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial" CONCLUSIONS: Therefore, topiramate plus phentermine with office based lifestyle interventions, such as those used in this study, could be a valuable addition to the small arsenal of effective obesity treatments that are available to family doctors. I am usually very critical with "magical" new Pills. But the numbers regarding weight reduction, cardiovascular risk factors improvements, with an acceptable overall side-effects profile has made myself (and the FDA) sensitive to give this combination Pill with central nervous system actions a fair chance in the market. All Best, Joey |
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Re: Good News: FDA advisors recommend approval of Anti-Obesity drug, Qnexa.
posted at 27/2/2012 11:27 AM GMT
on bmj.com
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Posts: 366
First: 13/4/2011 Last: 16/5/2012 |
In Response to Re: Good News: FDA advisors recommend approval of Anti-Obesity drug, Qnexa.: Hi Joey,Does this mean that you will be able to prescribe this drug for your patients? Would it be effective in all cases of obesity and how does it actually work? Hopefully it will be a really effective medication to reduce obesity. Regards, Kirked Posted by kirked Hello Kirked: Yes I will be able to use it. It has multiple ways of action. Not all patients will respond, but my guess is that the majority will, Topiramate has been used for all kind of addictions (Now it seems even for food addiction.....) I am glad that this Pill is being proposed to be prescribed by family doctors. In my humble opinion this new Pill has a strong lobby from the big PHARMAs against her, but for now it is just a suspicion.. All Best, Joey
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Re: Good News: FDA advisors recommend approval of Anti-Obesity drug, Qnexa.
posted at 27/2/2012 3:48 PM GMT
on bmj.com
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Posts: 275
First: 13/4/2010 Last: 15/5/2012 |
Thanks for the link Joey - figures do look good (although one swallow does not a summer make as they say) so will definitely keep an eye on this one. |
Forums » Open clinical » Diabetes » Good News: FDA advisors recommend approval of Anti-Obesity drug, Qnexa.
