Qnexa Is Rejected by an FDA Panel

As reported before on this blog, there are at least three obesity drugs being reviewed by the FDA that show weight management promise. The companies, developing these drugs, are the California based, Vivus, Arena and Orexigen. Vivus manufactures the drug Qnexa. Arena makes the drug Lorcaserin, and Orexigen produces the drug Contrave. But Vivus, with its drug Qnexa, is currently dominating the news because Qnexa shows a good bit of promise as a weight loss drug. However, Qnexa was recently rejected by an FDA advisory panel.

Qnexa is a combination of two drugs: phentermine and topiramate. Phentermine was used in the obesity drug combination fen-phen. Fenfluramine and Phentermine were fen-phen. Fen-phen was taken off the market in the 90s, at the request of the FDA, because of severe side effects, including cardiovascular problems. But phentermine was the safer of the two drugs.

Although Qnexa was effective in weight loss, the FDA panel had some misgivings about the drug when taken in high doses. For example, a larger number of study participants withdrew from the drug's clinical trials than participants on a placebo.

Further, study participants on the drug experienced thoughts of suicide, anxiety, palpitations, and problems concentrating, in higher numbers than the placebo group. Also, the participants on the drug suffered four heart attacks, while the placebo group didn't suffer any heart attacks. Finally, the FDA panel questioned whether the drug might cause birth control prescription drugs to be less effective.

It is for these reasons that the panel is advising the FDA not to approve Qnexa. However, the vote was nine to seven against approval, representing a very close vote. In fact, some who voted against the drug indicated that the FDA could approve the drug, with regulations. So, Qnexa still has a chance of approval by the FDA.

If the FDA does approve the drug, it would enjoy a waiting market. The market for obesity drugs is potentially lucrative. And Qnexa could profit from the market. “JMP securities recently projected Qnexa's annual sales would hit $1.5 billion by 2015.”

With the weight loss industry in need of a safe and effective weight loss drug, weight loss service providers should closely monitor Qnexa. And if the FDA does approve the drug, these providers will have a new tool to use in the weight management fight.

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Tags: environmental scanning, strategic management, Vivus, Qnexa, opportunities, threats, trends

Changes in School Reduced Childhood Obesity

As we have noted on this blog before, childhood obesity is a serious problem worldwide. And in the U.S., school districts are taking measures to deal with the problem. One of the measures being taken is an effort to make school cafeteria food healthier. Indeed, a recent study has shown that, along with taking other actions, putting healthier food in cafeterias can improve childhood weight management.

The study was a three year government study. The study's researchers made food and physical activity changes, and then followed 4,600 middle school students to examine the students' responses to the changes . The changes the researchers made included putting healthier food in the students' cafeteria, and improving the food available in other places the students might eat, such as snack bars, class events and vending machines. The students' school physical activities were also increased. These interventions improved the health of the students.

For example, the middle school students in the study experienced reduced fat in the abdomen and improved insulin sensitivity. And students in the study "who began the sixth grade overweight or obese were 21 percent less likely to be obese in three years."

School districts around the country -- and the world -- might review the study results and use them to enhance childhood weight management methods. Further, weight loss practitioners could work with school districts to help the districts establish healthier activities at the school site and the surrounding area. The weight management practitioners could also work with parents to help them introduce healthier diets and more physical activity in the home.

Reducing childhood obesity is important to schools and to parents. Since obesity can be an impediment to future success, bariatric or medical weight loss practitioners should be welcomed by schools districts and parents in the fight to curb obesity during the middle school years.

Finally, the above study indicates that successful childhood weight management can be achieved by combining healthy food with increased physical activity. Therefore, a weight loss center that effectively promotes healthy-food and increased-activity measures could legitimately market itself as a leader in understanding and fighting childhood obesity.

(Please leave a comment by clicking on the "COMMENTS" link at the lower right part of this blog post. SUBSCRIBE to this blog by scrolling to the bottom of this page and entering your email address.)
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Tags: environmental scanning, strategic management, childhood obesity