VIVUS, Inc. announced the results of a pharmacokinetic (PK) and pharmacodynamic (PD) study (NCT02714062) demonstrating that Qsymia® (phentermine and topiramate extended-release) capsules CIV has favorable pharmacokinetic, efficacy, and safety/tolerability profiles when used for eight weeks to treat adolescents with obesity. The study was conducted in order to establish dosing levels for the ongoing Phase 4 post-marketing study of Qsymia in obese adolescents. The results have been published online in Diabetes, Obesity and Metabolism. 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.