by Isabelle Esteves

Created on: February 22, 2012

Qnexa is the first new diet pill to be developed in many years. It is a combination of two other drugs, the anticonvulsant drug topirimate and the diet drug phentermine, which when combined lead to weight loss. It is produced by Vivus Inc. of Mountain View California. It was first presented to the FDA for approval in 2010 and that approval was denied.  The

FDA however, did not totally rule out the possibility that the drug might at a future date be approved. They recommended that the company provide additional data proving the safety of the drug.

On Wednesday February 22, 2012 the FDA will again be hearing from those who are pushing for approval and also for those who feel that more study is needed. In advance of that, both Vivus and the Endocrinologic and Metabolic Drugs Advisory Committee have posted their reports on the FDA website.

The review from Vivus Inc. is 166 pages long. It reports that Qnexa is a “significant advancement in the medical treatment of obesity" gave a detailed explanation of how the drug will be of benefit to people who are obese. It also addressed some of the concerns expressed by the advisory committee about the potential for birth defects by outlining the company plans for keeping the drug out of the hands of women who may be at risk of pregnancy. 

The advisory committee posted a 200 page review which addressed both concerns and benefits of the drug. In the original rejection, there was concern about birth defects which might affect women who became pregnant while taking Qnexa. The risk, in the form of cleft palate, is still a part of this review. There is also concern that the drug can cause cardiac arrhythmia and according to the report “is associated with cognitive related adverse events; in particular, confusion, psychomotor slowing, difficulty with concentration and attention, memory impairment, and language difficulties.”

The advisory committee review however, is not all negative. They admit that the drug has shown itself to be effective in helping people who are obese to lose approximately 5% of their total body weight. By doing that, it has also helped with some of the medical issues that go along with obesity. These medical issues include diabetes, high blood pressure and high cholesterol.

Some members of the medical community believe that the FDA has made it too hard for diet drugs to receive approval and it has been 13 years since a diet drug received approval.  Vivus Inc. is optimistic that approval will be forthcoming after the February 22, 2012 approval hearing.

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