For patients 6 years and older with ADHD
DYANAVEL XR Tablet Was Studied in Adults
From 30 Minutes to 14 Hours1
The effect of DYANAVEL XR tablet on symptoms of ADHD in adults was measured by PERMP-T* scores1,2
- The primary efficacy endpoint—the mean PERMP-T score across all postdose time points at Visit 5 (last visit)—was met (DYANAVEL XR (amphetamine) tablet: 302.8 [87.57†]; placebo: 279.6 [79.77†]; P=0.0043)
Improvement in Attention With DYANAVEL XR Tablet vs Placebo1
The response over time of DYANAVEL XR tablet was also measured by comparing PERMP-T scores between groups at all time points postdose.
Post hoc analysis by sequential time points: PERMP-T scores at 30 minutes and 1, 2, 4, 8, and 13 hours
postdose were statistically significantly higher with DYANAVEL XR tablet compared with placebo (P≤0.05)2
Study Design: This study employed a 5-week forced dose–titration phase. Eligible subjects aged 18 to 60 years were randomized to either oral, double-blind DYANAVEL XR tablet 5-mg starting dose or matching placebo once daily in the morning, beginning the day after the baseline visit. Subjects were titrated up (5-mg increments) each week. Safety and efficacy assessments were done weekly. After Visit 3, subjects received 20 mg for 14 (±3) days before Visit 5. Subjects who could not tolerate the study drug were discontinued. A PERMP placement test was done at screening or baseline. At Visit 5, efficacy assessments included the administration of serial PERMPs predose and 0.5, 1, 2, 4, 8, 10, 12, 13, and 14 hours postdose.1,2
DYANAVEL XR tablet
The PERMP is a validated, time-sensitive, skill-adjusted test consisting of math problems to be completed at multiple time points (administration of serial PERMPs). It is a robust, objective measure of the ability to initiate a task, self-monitor/stay on task, and complete written seatwork. The PERMP does not test for mathematical ability or the ability to learn math because the difficulty of problems is adjusted to the existing math skill level of each participant.2
PERMP-T, Permanent Product Measure of Performance Total.
References: 1. Cutler AJ, Pardo A, King TR, Rafla E, Duhoux S, Kando JC. Poster presented at: The American Professional Society of ADHD and Related Disorders; January 15-17, 2021; virtual conference. 2. Data on file. Tris Pharma, Inc.