For patients 6 years and older with ADHD
DYANAVEL XR (amphetamine) tablet is proven to be bioequivalent to
DYANAVEL XR oral suspension.1 Learn more about Dyanavel XR Tablet
DYANAVEL XR Oral Suspension Starts Fast and Lasts2


Statistically Significant Improvement in Attention and Behavior With DYANAVEL XR vs Placebo2


A lower SKAMP* score indicates an improvement in attention and behavior2
The primary endpoint—change from predose in SKAMP-Combined score at 4 hours postdose—
was significantly improved in the DYANAVEL XR group compared with that in the placebo group2
LS mean: DYANAVEL XR oral suspension, -8.8; placebo, 6.0
LS mean difference: -14.8 (95% CI: -17.9, -11.6; P<0.0001)
PERMP Scores Were Significantly Better With DYANAVEL XR for up to 13 Hours Postdose vs Placebo2


- One of the secondary endpoints was change from predose PERMP scores at 1, 2, 4, 6, 8, 10, 12, and 13 hours postdose2
- PERMP is a 10-minute written test with the number of problems attempted and the number of problems answered correctly used as measures of a patient’s performance2
- PERMP scores (problems attempted and problems answered correctly) were significantly improved with DYANAVEL XR (amphetamine) at all postdose time points compared with placebo (P<0.0001 for both)2
PERMP Test Examples
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.3
Shown below are examples of PERMP test results from an actual patient in the clinical study.
Open-Label Period
Practice Laboratory School Day (Vist 7)
DYANAVEL XR at 1 hour

Double-Blind Period
Complete Laboratory School Day (Vist 8)
Placebo at 1 hour

Study Design: One-week, randomized, double-blind, placebo-controlled laboratory classroom assessment of attention and behavior, scored by teachers and raters using the SKAMP rating scale in children aged 6 to 12 years (N=108) who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for ADHD. Classroom assessment followed a 5-week, open-label, dose-optimization period, where subjects initially received 2.5 mg or 5 mg DYANAVEL XR once daily in the morning. The dose was titrated by 2.5 mg to 10 mg every 4 to 7 days until an optimal dose or the maximum dose of 20 mg/day was reached. The primary endpoint was change from predose in SKAMP-Combined score at 4 hours postdose. Key secondary endpoints were onset and duration of clinical effect. The change in scores from predose SKAMP-Combined scores at postdose time points (1, 2, 4, 6, 8, 10, 12, and 13 hours) was used to evaluate key secondary efficacy parameters.2
Safety data forDYANAVEL XR oral suspension
*
The SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) rating scale, often used in clinical trials, is a validated rating instrument, used by trained raters to specifically measure the observed classroom manifestations of ADHD. The items of the SKAMP are specific for place (the classroom) and time (a typical class period). The scale’s items describe typical behaviors in a classroom setting, and additional items that describe behaviors associated with ADHD in the classroom. The SKAMP method of assessment has been demonstrated to be a sensitive measure of attention and behavior within a lab classroom setting.4
ADHD, Attention Deficit Hyperactivity Disorder; CI, confidence interval; LS, least squares; PERMP, Permanent Product Measure of Performance.
References: 1. Pardo A, Kando JC, King TR, Rafla E, Herman BK. CNS Spectr. 2020;25(6):774-781. 2. Childress AC, Wigal SB, Brams MN, et al. J Child Adolesc Psychopharmacol. 2018;28(5):306-313. 3. Data on file. Tris Pharma, Inc. 4. Wigal SB, Gupta S, Guinta D, Swanson JM. Psychopharmacol Bull. 1998;34(1):47-53.