2-Drug Combination Turned Down by FDA, but Company Plans to Try Again
The report published in The Lancet includes all the data that was already presented to the FDA last July by Vivus, the company developing the drug combination, Gadde says. However, he says, "this is the first time the data are presented in a peer-reviewed journal."
In July, an FDA expert advisory panel recommended against approval of Qnexa.
Since the rejection by the FDA advisory panel, the company has been addressing the concerns, says Peter Tam, the president of Vivus, which funded the study.
One concern is the use of topiramate, linked with birth defects such as cleft lip and cleft palate, by women who may become pregnant. Vivus is in discussion with the FDA now about how to address those concerns, Tam says.
"Our goal is to resubmit the new drug applications by the end of 2011," he says.
Qnexa: Study Details
For the study, researchers enrolled 2,487 participants, assigning them randomly to take either placebo pills or two different doses of the drug combination during the 56-week study.
In all, 2,448 patients were evaluated. This included 979 on placebo, 488 on the lower-dose regimen, and 981 on the higher dose. The lower dose included 7.5 milligrams of phentermine and 46 milligrams of topiramate. The higher dose was 15 milligrams of phentermine and 92 milligrams of topiramate.
To be eligible, patients had to have a body mass index of 27 to 45. No lower limit of BMI was in place for participants with diabetes. They also had to have two or more obesity-related conditions, such as high blood pressure or type 2 diabetes managed with lifestyle changes and/or the drug metformin.