DYANAVEL® XR delivers
Continuous symptom control with no return to baseline in an optimized-dose, double-blind phase 3 study1,2
Eligible patients may PAY $25
Learn more about Savings & SupportDYANAVEL XR (amphetamine) tablet is proven to be bioequivalent to DYANAVEL XR oral suspension.3 See PK Data.
Statistically Significant Improvement in Attention
and Behavior with DYAVAVEL XR vs Placebo1
- A lower SKAMP* score indicates an improvement in attention and behavior1
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 group1
LS Mean Change from Predose at 4 hours postdose: DYANAVEL XR oral suspension, -8.8; placebo, 6.0
LS Mean Treatment Difference: -14.8 (95% CI: -17.9, -11.6; P<0.0001)
PERMP Scores Were Significantly Improved With
DYANAVEL XR for up to 13 Hours Postdose vs Placebo1
- One of the secondary endpoints was change from predose PERMP scores at 1, 2, 4, 6, 8, 10, 12, and 13 hours postdose1
- 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 performance1
- 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)1
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.4
Shown below are the examples of PERMP test results from an actual patient in the clinical study.
Open-Label Period
Practice Laboratory School Day (Visit 7)
DYANAVEL XR at 1 hour
Double-Blind Period
Complete Laboratory School Day (Visit 7)
Placebo at 1 hour
Study Design: This dose-optimized, randomized, double-blind, placebo-controlled laboratory classroom study included 99 children aged 6 to 12 years who met DSM-IV-TR criteria for ADHD. In the 5 week open-label dose-optimization period, patients received a starting dose of 2.5 or 5mg of DYANAVEL XR taken once daily in the morning. The dose was titrated by 2.5mg to 10mg increments every 4 to 7 days until an optimal dose or the maximum daily dose of 20mg/day was reached. Patients who achieved an optimal dose during the dose optimization period entered the double blind portion of the study where they were randomized to either DYANAVEL XR at their optimal dose or placebo once daily for one week. Efficacy was assessed on the final day of the double-blind phase, by teachers and raters using the SKAMP rating scale. The primary endpoint was the change from predose in the model-adjusted average of SKAMP-combined score at 4 hours postdose. Secondary endpoints looked at change from predose SKAMP-combined scores at 1, 2, 4, 6, 8, 10, 12 and 13 hours postdose.1
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.5
ADHD, Attention Deficit Hyperactivity Disorder; CI, confidence interval; LS, least squares; PERMP, Permanent Product Measure of Performance.
References: 1. Childress AC, Wigal SB, Brams MN, et al. Efficacy and safety of amphetamine extended-release oral suspension in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psycholpharmacol. 2018;28(5):306-313. 2. Dyanavel XR [package insert]. Tris Pharma, Inc., Monmouth Junction, NJ. 3. Pardo A, Kando JC, King TR, Rafla E, Herman BK. CNS Spectr. 2020;25(6):774-781. 4. Data on file. Tris Pharma, Inc. 5. Wigal SB, Gupta S, Guinta D, Swanson JM. Psychopharmacol Bull. 1998;34(1):47-53.