VIVUS Secures Approval to Extend QSIVA® Use to Adolescents with Obesity

AMSTERDAM, Oct. 19, 2026 /CourierPR/ -- VIVUS, a biopharmaceutical company, has secured a landmark approval in Europe to extend the use of QSIVA® (phentermine/topiramate MR) to adolescents aged 12 years and older with obesity. This decision, which was reached through a variation procedure involving the national medicines agencies of 17 European countries, marks a significant step in addressing the pressing public health challenge of adolescent obesity.

The positive outcome of the variation procedure was based on results from a 2022 study, a double-blind, placebo-controlled clinical trial that evaluated the safety and efficacy of phentermine/topiramate MR over a 56-week period in 223 adolescents with obesity. This study demonstrated that QSIVA® can be a valuable tool in managing weight alongside diet and exercise, potentially preventing long-term complications.

QSIVA® is already approved in 17 European countries for weight management in adults. With the new indication, healthcare providers will have a therapeutic option to help adolescents manage their weight, providing a critical intervention before long-term health issues set in. The national medicines agencies of the 17 countries involved are expected to issue their decisions in as little as 30 days.

Globally, obesity and overweight pose significant public health challenges, impacting millions of people across Europe. These conditions increase the risk of various health problems, such as heart disease and autoimmune diseases, such as multiple sclerosis, Crohn’s disease, arthritis, and type 1 diabetes. The approval of QSIVA® for adolescents underscores VIVUS's commitment to advancing treatments for patients with serious unmet medical needs.

In the United States, QSIVA® (QSYMIA®) has been available since 2012 and its indication was extended to adolescents aged 12 years and older on June 27, 2022. In March 2025, VIVUS launched QSYMIA® in the United Arab Emirates for adults and pediatric patients aged 12 and older, marking the company’s entry into the MENA region.

The approval of QSIVA® for adolescents in Europe is a testament to VIVUS's dedication to addressing the needs of patients with serious unmet medical needs. The company continues to focus on developing innovative therapies that can make a meaningful difference in the lives of those affected by obesity and other serious conditions.