The Food and Drug Administration (FDA) has approved Dyanavel® XR (amphetamine), extended-release oral tablets, for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older.
Dyanavel XR tablets, a Schedule II controlled substance, contains amphetamine in a 3.2:1 ratio of d– and l– amphetamine. Treatment is administered once daily in the morning and may be chewed or swallowed whole.
Dyanavel XR tablets should not be substituted for other amphetamine products on a milligram-per-milligram basis due to different pharmacokinetic profiles and amphetamine salt compositions. Dyanavel XR tablets will be supplied as 5mg, 10mg, 15mg, and 20mg tablets and is expected to be available in the first quarter of 2022. The 5mg tablets are functionally scored and may be divided into equal halves (2.5mg).
The approval was based on data from a clinical study in healthy adults which showed that treatment with Dyanavel XR tablets were bioequivalent to the currently available Dyanavel XR oral suspension. The approval is also supported by data from a double-blind, placebo-controlled, fixed-dose phase 3 study (ClinicalTrials.gov Identifier: NCT03834766) that evaluated Dyanavel XR tablets in adults with ADHD.
Results from the phase 3 study showed that Dyanavel XR tablets achieved statistically significant improvements in mean Permanent Product Measure of Performance Total (PERMP-T) scores averaged across all post-dose time points (0.5, 1, 2, 4, 8, 10, 12, 13, 14 hours) compared with placebo (302.8 vs 279.6; P =.0043). Treatment with Dyanavel XR tablets had significant improvements in PERMP-T scores as early as 0.5 hours (P =.0115) and sustained through 13 hours (P =.0056) post-dose.
As for safety, the most common adverse reactions (incidence at least 5%) were insomnia, dry mouth, headache, irritability, nausea, dizziness, initial insomnia and tachycardia.
“The Dyanavel XR tablet represents an important treatment option for patients with ADHD,” said Andrew J. Cutler, CMO, Neuroscience Education Institute and Clinical Associate Professor of Psychiatry, 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.”
Dyanavel XR oral suspension is currently available as 2.5mg/mL of amphetamine in 464-mL bottles.
- Tris Pharma announces FDA approval of Dyanavel® XR (amphetamine) once-daily extended-release oral tablets, CII, for ADHD. News release. Tris Pharma, Inc. Accessed November 5, 2021. https://prnmedia.prnewswire.com/news-releases/tris-pharma-announces-fda-approval-of-dyanavel-xr-amphetamine-once-daily-extended-release-oral-tablets-cii-for-adhd-301417528.html.
- Tris Pharma presents positive results from phase 3 study of amphetamine extended-release tablet in adults with ADHD. News release. Tris Pharma, Inc. January 20, 2021. Accessed November 5, 2021. https://www.trispharma.com/who-we-are/news-and-media/tris-pharma-presents-positive-results-from-phase-3-study-of-amphetamine-extended-release-tablet-in-adults-with-adhd/.
- Dyanavel XR. Package Insert. Tris Pharma, Inc.; 2021. Accessed November 5, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210526s000lbl.pdf.