Tris Pharma Releases ADHD Tablets

 Tris Pharma Releases ADHD Tablets

Tris Pharma announced that DYANAVEL® XR (amphetamine) extended-release tablets, for oral use, CII are now available in pharmacies. DYANAVEL XR was approved by the U.S. Food and Drug Administration for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

In a double-blind, placebo-controlled, fixed-dose Phase 3 study in adults with ADHD, DYANAVEL XR tablets demonstrated statistically significant improvement versus placebo in mean Permanent Product Measure of Performance Total (PERMP-T) scores averaged across all measured post-dose time points (0.5, 1, 2, 4, 8, 10, 12, 13, and 14 hours post-dose). The PERMP-T is a validated and FDA-accepted, skill-adjusted, timed math test that is used to assess attention in people with ADHD. The most common adverse events included headache, decreased appetite, irritability, initial insomnia, insomnia, dry mouth, anxiety, dizziness, tachycardia, fatigue, and nausea. Most treatment-emergent AEs (TEAEs) were mild to moderate in severity, and no SAEs were reported during the study. These finds were recently published in The Journal of Clinical Psychiatry (Cutler, et al. J Clin Psychiatry 2022. 83(00):22m14438).

In another clinical study in healthy adults, DYANAVEL XR extended-release tablets were deemed to be bioequivalent to DYANAVEL XR (amphetamine) extended-release oral suspension CII, which in a Phase 3 clinical study of children aged 6 to 12 years with ADHD, demonstrated ADHD symptom improvement within 1 hour, that lasted through 13 hours after once-daily dosing. Further, in a separate exploratory study, DYANAVEL XR oral suspension appeared to improve ADHD symptoms as soon as 30 minutes after dosing (Pardo, et al. CNS Spectrums 2020 Dec:25(6):774-781).


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