VIVUS Announces New Data Supporting the Safety and Efficacy of Qsymia® in Adolescents with Obesity
-Data published in Diabetes, Obesity and Metabolism demonstrate that Qsymia provides statistically significant weight loss compared with placebo over an 8 week period, provide basis for ongoing 56 week phase 4 study in obese adolescents-
“Over the past 30 years, childhood obesity has become an epidemic and continues to be a major public health concern, with obesity rates currently over 18% for those between the ages of 12 and 19 years based on U.S. government data2,” said
This randomized, double blind, placebo-controlled, study was conducted at four U.S. sites and enrolled 42 participants ages 12-17 years with a body-mass index (BMI) greater than or equal to the 95th percentile for age and sex. The study consisted of a 14-day (maximum) screening period followed by a 56-day treatment period. Eligible participants were randomly assigned in a 1:1:1 ratio to placebo, mid-dose Qsymia or top-dose Qsymia. Within each active treatment arm, doses were titrated at two-week intervals starting with low dose Qsymia and increasing until the randomized dose was achieved. Participants assigned to placebo underwent a sham titration to ensure that both participants and site personnel remained blinded to treatment assignment. The primary objective of the study was to describe the PK profiles of Qsymia after administration in adolescents with obesity.
Key findings from the study include:
- The study authors conclude that both the mid- and top-doses of Qsymia evaluated in this study are appropriate for longer-term safety and efficacy study in adolescents.
- PK analyses were conducted in 26 patients in the Qsymia groups (14 mid-dose and 12 top-dose), and results show that exposure to the mid- and top-dose Qsymia groups was comparable to that observed in prior studies of Qsymia in overweight and obese adults.
- Significant differences from baseline to Day 56 were observed with respect to mean percentage change in weight for both Qsymia groups compared with placebo (-3.72%, -4.96% and +1.06% for the mid- and top-dose Qsymia groups and placebo group, respectively); and for mean change in waist circumference and hunger scores for the top-dose Qsymia group compared with placebo (-2.8 cm, -4.9 cm, and +0.3 cm for the mid- and top-dose Qsymia groups and placebo group, respectively).
- Treatment emergent adverse events were reported in 54.8% of the 42 patients who entered the trial; specific events reported by two or more subjects included headache, paresthesia, hypoesthesia, dry mouth, decreased appetite, and insomnia. All of these have been observed in previous studies with Qsymia.
- Of the 42 patients enrolled, 37 (88.1%) completed the study, indicating tolerability of Qsymia.
“These findings add to the growing body of data supporting the safety and clinical benefit of Qsymia in diverse patient populations,” said
1 Hsia DS, Gosselin N, Williams J, Farhat N, Marier JF, Shih W, et al. A randomized, double-blind, placebo-controlled, pharmacokinetic and pharmacodynamic study of a fixed-dose combination of phentermine/topiramate in adolescents with obesity. Diabetes, Obesity and Metabolism. doi: 10.1111/dom.13910.
2 Hales CM, Fryar CD,
Qsymia is approved in the United States and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.
The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.
Important Safety Information
Qsymia (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors; or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.
Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.
The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.
VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs. For more information about VIVUS, please visit www.vivus.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks, uncertainties and other factors, including risks and uncertainties related to our ability to execute on our business strategy to enhance long-term stockholder value; risks and uncertainties related to our ability to address our outstanding balance of the convertible notes due in
Chief Financial Officer
|Investor Relations: Lazar FINN Partners
Source: VIVUS, Inc.