VIVUS LLC announced positive topline data from a post-marketing study to evaluate the effect of QSYMIA (phentermine and topiramate extended-release capsules CIV) on 24-hour ambulatory blood pressure (ABPM) (#NCT05215418). This study, which enrolled patients with overweight or obesity who also had at least one weight-related comorbidity (i.e., hypertension, dyslipidemia, impaired fasting glucose or glucose tolerance, type 2 diabetes mellitus, or obstructive sleep apnea) demonstrated that QSYMIA treatment for eight weeks was associated with reductions in systolic blood pressure as assessed by ABPM compared to both placebo and phentermine. Obesity and high blood pressure are significant risk factors for the development of cardiovascular disease.

VIVUS currently is discussing the results of the double-blind study conducted in 565 overweight/obese adult subjects who were randomized (1:1:1) to an eight-week course of once-daily placebo, QSYMIA (15 mg phentermine/92 mg topiramate) or phentermine (30 mg) with the U.S. Food & Drug Administration and expects to present or publish the complete study results in a peer-reviewed forum. The Institute for Clinical and Economic Review's (ICER) Evidence Report, dated August 2022, assessed the comparative clinical effectiveness and value of treatments for obesity management. Results showed that VIVUS' QSYMIA was more cost effective for weight loss than other weight loss drugs, including newer injectable medications.

QSYMIA is the leading non-injectable weight loss medication in the U.S. for adults. QSYMIA is indicated as an FDA-approved adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in some adults and certain pediatric patients aged 12 years and older. The once-daily pill is currently covered by the majority (81%) of commercial healthcare plans and is indicated for long-term use.