Extended Release Amphetamine Now Available for Children and Adults With ADHD

After receiving US Food and Drug Administration approval last fall, Dyanavel XR (amphetamine) extended-release tablets are now available in pharmacies for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients 6 years and older, maker Tris Pharma Inc. announced.

“Due to Tris's proprietary LiquiXR technology, this is the first ADHD product that gives adult patients a choice when an early onset is desired without sacrificing full-day coverage,” said James Hackworth, PhD, president of the branded products division at Tris. “We expect that this product will fill a big current gap in treatment options and help patients to not have to choose between early morning and evening coverage.”

In a double-blind, fixed-dose, phase 3 study of adults with ADHD, Dyanavel XR tablets demonstrated significant improvement compared with placebo in Permanent Product Measure of Performance total scores averaged across all measured post-dose time points (0.5, 1, 2, 4, 8, 10, 12, 13, and 14 hours post-dose). The most common adverse events included headache, decreased appetite, irritability, initial insomnia, insomnia, dry mouth, anxiety, dizziness, tachycardia, fatigue, and nausea.

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Dyanavel XR extended-release tablets were deemed to be bioequivalent to Dyanavel XR extended-release oral suspension in another study of healthy adults. In an earlier phase 3 study of children ages 6 to 12 years with ADHD, Dyanavel XR extended-release oral suspension demonstrated symptom improvement within 1 hour, which lasted through 13 hours. In a separate exploratory study, Dyanavel XR oral suspension appeared to improve ADHD symptoms as soon as 30 minutes after dosing, Tris Pharma reported.

“The Dyanavel XR tablet represents an important treatment option for patients with ADHD,” said Andrew J. Cutler, MD, clinical associate professor of psychiatry at SUNY Upstate Medical University, Syracuse, New York.

“Knowing that ADHD in adults presents differently than in children, and as different adults have different treatment goals, Dyanavel XR once-daily tablet was designed and developed with the intent to provide adults with ADHD a treatment option that kicks in quickly and lasts throughout their workday and beyond.”

Reference

Tris Pharma announces availability of new Dyanavel XR (amphetamine) tablets for ADHD. News release. Tris Pharma; August 16, 2022. Accessed August 19, 2022.