The FDA has approved Dyanavel XR, extended release once-daily tablets for the treatment of attention-deficit/hyperactivity disorder.
The US Food and Drug Administration has approved Tris Pharma’s Dyanavel XR (amphetamine), extended release once-daily tablets for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older.
“The Dyanavel XR Tablet represents an important treatment option for patients with ADHD,” said Andrew J. Cutler, CMO, of the Neuroscience Education Institute and clinical associate professor of psychiatry at the SUNY Upstate Medical University. “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.”1
Dyanavel XR is a central nervous system stimulant prescription medicine used for the treatment of ADHD in individuals aged 6 years and older.
There is a significant body of research to support this approval. In a clinical study, Dyanavel XR extended-release tablets were deemed to be bioequivalent to Dyanavel XR extended-release oral suspension. In a phase 3 study of children aged 6 to 12 with ADHD, demonstrated ADHD symptom improvement occurred within 1 hour and lasted 13 hours after once-daily dosing. Additionally, in an exploratory study, Dyanavel XR oral suspension appeared to improve ADHD symptoms as quickly as 30 minutes after dosing.2
“Dyanavel XR oral suspension and now Dyanavel XR tablets provide a unique pharmacokinetic profile and a broad range of dosing options for patients needing an amphetamine for their ADHD,” said James Hackworth, PhD, President of the Tris Branded Products Division.
Dyanavel XR tablets demonstrated statistically significant improvement versus placebo in mean Permanent Product Measure of Performance Total (PERMP-T) scores averaged across all post-dose time points measured in a separate double-blind, placebo-controlled, fixed-dose phase 3 study in adults with ADHD. The PERMP-T—a validated and FDA-accepted, skill-adjusted, timed math test—is used to assess attention in people with ADHD. The most common adverse reactions experienced by participants were insomnia, dry mouth, headache, irritability, nausea, dizziness, initial insomnia, and tachycardia.
As it contains amphetamine, Dyanavel XR is a federally controlled substance (CII). Dyanavel XR tablets are expected to be stocked in pharmacies in the first quarter of 2022.
1. Tris Pharma announces FDA approval of Dyanavel XR (amphetamine) once-daily extended-release oral tablets, CII, for ADHD. BioSpace. News release. November 5, 2021. Accessed November 8, 2021. https://www.biospace.com/article/releases/tris-pharma-announces-fda-approval-of-dyanavel-xr-amphetamine-once-daily-extended-release-oral-tablets-cii-for-adhd/
2. Pardo A, Kando JC, King TR, et al. Single-dose pharmacokinetics of amphetamine extended-release tablets compared with amphetamine extended-release oral suspension. CNS Spectr. 2020;25(6):774-781.