Tris Pharma announced the publication of a Phase 3 study in the Journal of Clinical Psychiatry that demonstrated that adult patients with ADHD who took DYANAVEL XR (amphetamine) tablets CII had statistically significant improvement in symptoms over patients who took placebo.
The study was a Phase 3, randomized, double-blind, placebo-controlled, fixed-dose study designed to assess the efficacy and safety of DYANAVEL XR tablets in adult patients with ADHD. The efficacy assessment included the administration of serial Permanent Product Measure of Performance (PERMP) tests pre-dose and at 0.5, 1, 2, 4, 8, 10, 12, 13, and 14 hours post-dose. The mean PERMP Total (PERMP-T) score across all post dose time points – the primary efficacy endpoint – was statistically significantly higher in the DYANAVEL XR tablet group compared with placebo (302.8 vs 279.6; p=0.0043). Additionally, statistically significant improvements (increase) in PERMP-T scores were observed in the DYANAVEL XR tablet group at 0.5 hours (p=0.01), 1 hour (p< 0.001), 2 hours (p= 0.0003), 4 hours (p = 0.031), 8 hours (p = 0.026), and 13 hours (p=0.006) post dose compared with placebo. Numerical differences favoring the DYANAVEL XR tablet group were seen at the 10-, 12-, and 14-hour time points as well, however those differences were not statistically significant when compared to placebo. 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.