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Qnexa: Miracle diet drug?

by Kathy Stemke

Created on: July 23, 2010

We can walk on the moon, but scientists can’t produce a diet pill that works without dangerous side effects.  With U.S. obesity rates nearing 35 percent of the adult population, the quest for a magic weight loss drug is intensifying. 

The history of diet drugs is littered with failures.  Fen-phen, was pulled off the market due to links to heart valve and lung damage.  Two years ago studies were discontinued for Acomplia, due to psychiatric side effects.  And in May, the FDA warned consumers that Alli, could cause severe liver damage.

 Physicians and patients are dissatisfied with the efficacy, safety and tolerability of currently marketed obesity drugs. The demand for a miracle weight loss pill is great, and the potential to make billions of dollars in a wide open market is real.   

 Although pharmaceutical companies have made little headway in understanding and treating the causes of overeating, there are several weight loss drugs set for review by the FDA this year.  They are Lorcaserin, Contrave, and Qnexa. 

Qnexa, a combination drug, is made up of the previously approved Phentermine, which is of the amphetamine class that surpresses appetite, and Topamax, an approved anticonvulsant, which gives you the feeling of satiation.  In their latest clinical trials, patients taking Qnexa lost between 13 percent and 15 percent of their body weight.  Vivus also reported that the drug reduced blood lipids and blood sugar levels

Recently, The FDA voted 10-6 against Vivus Inc.'s diet drug, Qnexa, citing unknown safety risks of long-term use with the drug.  The side effects included memory loss, suicidal thoughts, heart palpitations, birth defects and concentration problems.  Study patients taking high doses of the medicine, were four to seven times more likely to stop treatment due to anxiety, depression and sleep- related complications, Food and Drug Administration staff said.  The FDA usually recommends the advice from their advisory panel and some feel the vote was close enough thus creating a slight argument that it could still be approved.

 Vivus Inc. is not giving up on their promising drug. CEO Leland Wilson, disappointed with the Committee's vote, vowed to continue to work closely with the FDA to address the labeling and safety questions raised.

 Orexigen Therapeutics Inc.'s Contrave is set for FDA review in October, and Arena Pharmaceuticals Inc.'s Lorcaserin is on the calendar in December.  Decision Resources, a drug industry analysis firm, believes all three drugs could eventually win approval and find a place in the global weight loss market. The firm expects the global market to soar from $500 million to $3.4 billion a year by 2018.

 http://www.medicalnewstoday.com/articles/195035.php

 http://www.physorg.com/news198436147.html

 http://www.dresources.com/

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