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# FDA Won’t Require Qsymia CV Outcome Trial
- URL: https://www.fdaweb.com/fda-wont-require-qsymia-cv-outcome-trial/
- Published: 2024-10-29T12:00:00.000Z
- Updated: 2026-09-14T14:45:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158081

FDA has notified Vivus that it has removed the requirement for a cardiovascular outcome trial for its weight-management medication Qsymia (phentermine and topiramate extended-release capsules). An agency letter said that positive topline data from a postmarketing study evaluating the effect of Qsymia on 24-hour ambulatory blood pressure does not raise concerns about cardiovascular risk and further assessment through a dedicated outcome trial would not be additionally informative, a company [statement](https://www.vivus.com/pdf/press-releases/2024-10-28%5EQsymia%5EVIVUS%5FShares%5FSignificant%5FRegulatory%5FUpdate%5Fon%5FQSYMIA.pdf?ref=fdaweb.com) says.

Vivus says Qsymia was approved by FDA in 2012 and is the leading non-injectable branded weight-loss medication in the U.S. for adults. It is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long-term in adults and pediatric patients aged 12 and older with obesity, and in adults with overweight in the presence of at least one weight-related comorbid condition.