Another medication, called Qsymia, designed for obesity treatment and considered to be the most effective among the new generation of weight-loss drugs, was approved by the U.S. Food and Drug Administration (FDA) on Tuesday, July 17, 2012. This medication is approved for obese and overweight patients and those who also have at least one condition, which is related to obesity or overweight, like diabetes, high cholesterol or high blood pressure.
Qsymia will help those patients who failed to lose weight in other ways, like lifestyle changes or physical exercises. This medication demonstrates also the hard way of its creators: they needed to make the medication not only effective but also safe. The medication is planned to be released on the market Q4 of 2012, said Vivus Inc, the pharmaceutical company that developed the medication. Still, there is no information about the cost of Qsymia.
This approval for long-term weight-loss medication is the second for the last month and it follows the approval of Belviq, another weight-loss drug from Arena Pharmaceutical, that was approved on June 27, 2012. Since 1999, Belviq was the first medication approved for long-term treatment of obesity and overweight.
Here you can find the article about another weight-loss drugs approval.
Doctors have called on the FDA many times because the obesity rates among the adult population of the U.S. is about 35% and there were not many options for the treatment. Some of the options were used seldom because of their side effects. A good example of such medications is Xenical.
Another medication used for a long-term treatment was a combination of phentermine and fenfluramine (“fen-phen” for short). However, this combination was linked to side-effect, like heart valve damage in 1997 and it was not approved by the FDA. In 2010, Abbott Laboratories withdrew Meridia, its diet pills because of the increased risks of stroke and heart attack. Acomplia was another weight-loss drug, which was discontinued because of psychiatric adverse effects.
Like Belviq, Qsymia did not get its approve in 2010. The main reason for reject by FDA were concerns about medication effect on unborn children if taken by pregnant women. The special plan was developed to decrease the chance of women to get pregnant during the treatment. During the treatment, it is recommended to women make the pregnancy test monthly, as well as an initial test before the treatment start. However, patients with unstable heart disease or stroke should avoid taking the medication because it is unknown how it effects on heart rates. The FDA said that Vivus has to do some research and conduct studies to find out the effect of its medication on a hearth. Despite all the difficulties and safety issues, Belviq and Qsymia are approved by the FDA, which means the will of making weight-loss medications available.
Qsymia demonstrated the best results during clinical tests among other medications recently reviewed by the FDA. A year body weight loss was about 6.7% of the initial weight in patients who took Qsymia. Another study showed different result and it was 8.9% and patients who took the strongest formulation of Qsymia lost about 11% of their initial weight.
The results were quite impressive, but this medication doesn’t present some brand new features and it is not considered to be a breakthrough in science, since in consists of two drugs used for weight-loss medications. Those medications are topiramate and phentermine. The first one is an anticonvulsant that makes people feel satiety and another one is a stimulant which suppresses the appetite. Phentermine has been used for a long time as weight-loss medications for short-term treatment. Qsymia developers explained that the medication’s targets are some of the brain signals that make people overeating and this is the innovation of Qsymia.
Dr. Tim Garvey of the University of Alabama at Birmingham said that they knew about different pathways that determine how much energy people take in each day. He added that affect only on one of the pathways did not make any difference, so it was mandatory to attack multiple mechanisms to get the effect needed. He also helped in a few trials conductions.
Vivus is going to launch its medications with small sales forces. The number of representatives will be near 150 and their focus will be on obesity specialist, not primary care doctors. Peter Tam, president of Vivus, said in his interview with the Associated Press that they were going to have to grow their sales forces in order of primary care market support.
The original name of the Vivus medication should be Qnexa (this name was used in 2010), but FDA ordered the company to change the name of its medication to avoid an occurrence of different types of confusion with other medications with similar names.
Here is an article where you can find some examples.
Qsymia has several competitors. One of them is Belviq from Rival Arena Pharmaceuticals Inc., will be launched in early 2013. Another possible competitor is Contrave from Orexigen Therapeutics Inc. is still running its clinical trials and will be reviewed by the FDA in 2014.