Tuesday, July 20, 2010

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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