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A health advisory panel reports that Qnexa, an anti-obesity drug that was previously rejected by the Food and Drug Administration (FDA), should be approved soon. If it does gain approval, it will be the first prescription weight loss pill in 13 years.
The drug company Vivus is sprinting to be the first company to release a prescription diet pill onto the market in over ten years. The FDA will review their investigational weight loss pill Qnexa for a second time this month. The health advisory panel reports that the drug should finally be approved as the panel of physicians voted 20 to 2 in favor of this anti-obesity pill. While the FDA isn’t required to follow the advice of this panel, they often consider such recommendations.

Health Officials Back Qnexa

Qnexa came back up for review after it was studied by more extensive clinical trials. Public health officials back the drug, urging the FDA to consider this medication for treatment of a condition that now affects one-third of Americans. Qnexa is a combination drug of phenteramine and topiramate and is a once-per-day weight-loss therapy that combines two agents already approved by the FDA.

Obesity is a National Public Health Concern

Obesity can lead to other diseases like hypertension, diabetes mellitus, osteoarthritis, and heart disease. According to Vivus’ website, obesity is a major health concern that affects a growing proportion of the population. It is estimated that around 78 million American adults are obese or overweight. Besides its impact on health, obesity economically accounts for around 9 percent of annual healthcare spending- a whopping $150 billion dollars! If the current trend continues, Vivus predicts that by 2030 the healthcare cost attributable to obesity will reach over $950 billion.

The Research Supports Qnexa

The clinical studies conducted on Qnexa have shown significant weight loss, improvement in cardiovascular risk factors, and glycemic control. These findings were found when the drug was used in combination with diet and lifestyle modifications. A 56-week study, known as the EQUIP study, examined the safety and efficacy of Qnexa in 1,267 obese patients in the U.S. The results published in the medical journal Obesity found that the average weight loss for these participants was 14.4% for the top dose of the drug and 2.1% for those in the placebo group who did not get Qnexa.

Side effects that were reported by the participants included tingling, constipation, dry mouth, and altered taste. Vivus plans to market Qnexa only to people who meet the government’s definition of obesity: a BMI of 30 or greater. What’s more, those who do not lose 3% of their body weight after three months on the drug are advised to stop taking it.

Qnexa Poses some Safety Concerns

Qnexa merges low doses of the stimulant diet drug phenteramine (used for short-term weight loss) and the migraine and anti-seizure drug topiramate. The reason the drug was voted out last fall was that an FDA panel cited there were data showing that babies born to women who took topiramate had a great chance of developing cleft palate. The Vivus company president, Peter Tam, told WebMD that other studies found that the risk of this particular oral birth defect was quite less significant and based on some newfound information.

The FDA agreed for the company to resubmit its application for limited approval for use of those women who are not likely to become pregnant. Dr. Barbara Troupin, Vivus Medical Affairs Director, reported that the company plans to establish a pregnancy registry of infants born to women who took the drug while pregnant.