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Author: admin, 06.03.2014
A new weight-loss pill that many doctors consider the most effective of a new generation of anti-obesity drugs got the approval of the Food and Drug Administration on Tuesday. The pill, called Qsymia, was approved for patients who are overweight or obese and also have at least one weight-related condition such as high blood pressure, diabetes or high cholesterol. The drug offers hope for those who have failed to lose weight in other ways, but its path to approval also underscores how difficult it has been for drugmakers to find obesity treatments that are safe and effective. The drug's maker, Vivus Inc., said it plans to bring the drug to market in the fourth quarter of this year.
In testing, the drug made led patients to lose more weight than two other weight-loss pills recently review by the FDA.
Phentermine is a stimulant that suppresses the appetite, and has long been used for short-term weight loss. Qsymia is the second weight-loss drug approved by the FDA in less than a month, following Arena Pharmaceutical's pill Belviq in late June.


The FDA's approvals of Qsymia and Belviq suggest a new willingness to make weight-loss medications available, even in the face of lingering safety issues. The FDA initially rejected Vivus' drug in 2010 over concerns that it can cause birth defects if taken by pregnant women. The agency also said patients with recent or unstable heart disease or stroke aren't good candidates for the drug because its effect on heart rates in those patients is not known.
Analysts estimate the new pill could garner more than $1 billion in sales by 2016, though Mountain View, Calif.-based Vivus plans a slow rollout. The drug is actually a combination of two older drugs long known to help with weight loss: phentermine and topirimate. The cocktail of phentermine and fenfluramine was a popular weight-loss combination prescribed by doctors, though it was never approved by the FDA. In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased risks for heart attack and stroke.


The agency laid out a risk-management plan Tuesday specifically designed to minimize the chance of the women becoming pregnant while using the drug. However, FDA regulators ordered the company to change the name to avoid potential confusion with similar-sounding drugs. The company said patients on the strongest formulation tested lost nearly 11 percent of their weight.
It recommends that women of childbearing age test negative for pregnancy before starting the drug and take a monthly pregnancy test while taking it. A third California drugmaker, Orexigen Therapeutics Inc., is still running clinical trials of its product, Contrave, and is working toward an FDA approval date in 2014.



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