VIVUS Initiates Phase Four Safety and Efficacy Study of Qsymia

-Post-marketing study designed to evaluate Qsymia as an approach to weight management in a growing patient population with significant unmet medical need-

VIVUS, Inc. (Nasdaq: VVUS; the “Company”), a biopharmaceutical company, today announced that the first patient has been enrolled in a Phase four clinical study designed to evaluate the safety and efficacy of Qsymia^® (phentermine and topiramate extended-release) capsules CIV in obese adolescents between the ages of 12 and 17 years (NCT# 03922945).  The Centers for Disease Control and Prevention estimates that nearly 21 percent of adolescents ages 12 to 19 years are obese.¹  A study conducted by the World Health Organization found that obesity in children ages five to 19 years has risen ten-fold in the past four decades and estimates that more children globally will be overweight rather than underweight by 2022.²

“Adolescent obesity represents one of the most critical medical and public health issues not only because one out of five teenagers is affected, but also due to the fact that medical treatment options are limited,” said Aaron Kelly, PhD, Associate Professor of Pediatrics, Co-Director of the Center for Pediatric Obesity Medicine at the University of Minnesota, and an investigator on the trial. “Currently only one obesity medication for long-term use is approved for adolescents, and it is rarely prescribed because of its modest effectiveness and often intolerable side effects.  More options are needed, and a new clinical trial evaluating the safety and effectiveness of Qsymia in adolescents with obesity is very important for the field of pediatric obesity medicine.”

“Childhood and adolescent obesity is known to impact both physical and psychological health, and increases the risks of adult obesity, type 2 diabetes and lipid disorders,” said Santosh T. Varghese, MD, Chief Medical Officer at VIVUS. “If this trial is successful, Qsymia could play an important role in helping obese adolescents achieve healthier weight goals.”

The Phase four post-marketing study, which the U.S. Food and Drug Administration (FDA) required as part of the approval of Qsymia in 2012, is expected to enroll 200 patients at approximately 20 clinical sites in the United States.  The primary endpoint of the randomized, double blind, placebo-controlled, parallel-design study is the mean percentage change in body-mass index (BMI) in patients randomized 1:1:2 to daily mid- or top-dose Qsymia compared with placebo over 56 weeks of treatment.  Participants will also be instructed to follow a reduced-calorie diet and to implement a family-based lifestyle modification program that includes physical activity, behavioral change and family support. Safety and tolerability of Qsymia will also be assessed.

The Company expects to report top-line results from this Phase four trial in the second half of 2020.

https://www.globenewswire.com/news-release/2019/05/28/1853051/0/en/VIVUS-Initiates-Phase-Four-Safety-and-Efficacy-Study-of-Qsymia-in-Obese-Adolescents.html