Near Unanimous Vote on Anti-Obesity Drug, QNEXA

qnexa drugYesterday the FDA’s Advisory Committee cast nearly unanimous votes to recommend the approval of QNEXA, a new drug to treat those affected by obesity and obesity-related co-morbidities. The committee voted 20-2 in favor of approving the drug, which, if it gains final approval this April, would be the first anti-obesity drug approved by the FDA in the past ten years.

QNEXA could fill the treatment gap that currently exists: there are lifestyle changes like diet and exercise, and then there’s surgery, but nothing in between. The drug could help the millions of obese Americans who cannot achieve sustainable weight loss through diet and exercise alone, yet are not able to receive bariatric surgery either, or those who would be better suited to a less extreme option than surgery. QNEXA, made by Vivus, is one of three drugs currently seeking FDA approval. It’s a combination of phentermine (which suppresses appetite) and topiramate (which increases satiety – the feeling of fullness). QNEXA has been reported to induce the highest weight loss of any recent diet pill, with weight loss nearing 10 percent of body weight for most patients taking the drug for a year. It is very difficult to get weight loss drugs approved by the FDA. QNEXA has previously been rejected due to concerns that it can cause heart palpitations and birth defects if used during pregnancy.

In fact, finding an effective treatment for obesity has been quite a challenge. For the past century, drug makers have tried to create a drug that would help people lose weight without dangerous or embarrassing side effects. In the 1930’s, for example, doctors prescribed a chemical called dinitrophenol, which accelerated metabolism and did cause some weight loss, but also caused adverse effects including cataracts, blindness, and deaths. The FDA was later established in response to untested drugs like dinitrophenol. Today, Orlistat – sold as the prescription drug Xenical and over the counter as Alli — is the only drug approved for long-term weight loss in the United States.  Unfortunately, the drug has unpleasant stomach issues and often causes diarrhea, so it hasn’t had great traction.  You can read more about the history of obesity treatment here, beginning with archaic treatments such as bleedings and recommendations like ‘violent exercise’.

The FDA is expected to make a final decision on the request to approve QNEXA in the next several weeks or months.

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