DYANAVEL XR, Quillivant XR, and QuilliChew ER are federally controlled substances (CII) because they can be abused or lead to dependence. Keep these medicines in a safe place to prevent misuse and abuse. Selling or giving away these medicines may harm others and is against the law. Tell your doctor if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Learn about a clinical study with children that took DYANAVEL XR compared to those children that took a sugar syrup†
- One of the secondary measures was change from pre-dose Attention Test scores at 1, 2, 4, 6, 8, 10, 12, and 13 hours post-dose
- The Attention Test is a 10-minute written test with the number of problems attempted and the number of problems answered correctly used as a measure of a patient’s performance
- Attention Test scores (problems attempted and problems correct) were significantly improved with DYANAVEL XR (amphetamine) at all post-dose time points compared with placebo (P<.0001 for both)
The Study was performed in a laboratory classroom setting with children ages 6 to 12 with ADHD. At the end of each week, teachers and raters used a rating scale to evaluate the attention and behavior of the children who took DYANAVEL XR against the children taking the sugar syrup.
The Attention Test is a two-part test. It measures a child’s scores on:
- the number of problems attempted, and
- the number of problems solved accurately
Addition of the scores from each part provides that child’s Total Score on the Attention Test.
Higher Total Scores on the Attention Test reflect the child’s ability to pay attention for 10 minutes straight when seated in one place.
Using the Attention Test as a tool to measure the clinical benefit of an ADHD treatment in late-stage clinical studies is an objective way to measure the ability of a person with ADHD to pay attention and complete a task.
The Attention Test is made up of two parts:
- Each part is a single page of 80 different addition and subtraction problems, chosen based on results from a practice test administered to each child
- The first part measures the child’s ability to focus on and attempt to solve as many addition and subtraction problems from those assigned
- The second part measures the child’s ability to accurately answer a different set of such problems
Shown here are examples of an actual completed Attention Test with the same child, one with DYANAVEL XR, one with a sugar syrup.
Both tests were conducted at the same timepoint of the day, 1 hour after the treatment was administered to the child.
Sugar syrup at 1 hour
DYANAVEL XR at 1 hour
As illustrated here, patients who took DYANAVEL XR attempted and solved more problems than those who took the sugar syrup at this timepoint.
*Term for the Permanent Product Measurement of Performance test used in clinical trials of ADHD.
†In a clinical study performed in a laboratory classroom, DYANAVEL XR was found effective at reducing the symptoms of ADHD and improving performance in children ages 6-12 years at all measured times (1, 2, 4, 6, 8, 10, 12, and 13 hours after taking) compared to a sugar syrup.