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Can Vivus Get Away Without Outcomes Study Of Obesity Drug Qsymia?

 
• By Emily Hayes

Fixed-dose combination of phentermine and topiramate is FDA-approved for chronic, long-term use, but the average duration in the real world is only about 2.1 months, which is reassuring for Qsymia’s cardiovascular safety, according to a new retrospective claims study.

Fat sad man and his reflection in the mirror of a normal man against sky. Obesity concept - Illustration

Vivus Inc. is discussing results from a retrospective study of claims data for its obesity drug Qsymia with the US FDA, in hopes that the results may be incorporated into labeling and "reduce or modify the need for a cardiovascular outcomes study," the company said Jan. 14.

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