Tris Pharma — Dyanavel Xr FDA Review (NDA208147, ORIG 1, 2015)
Tris Pharma · 2015 · FDA Review (openFDA)
Report summary
The FDA review of Tris Pharma's Dyanavel XR (amphetamine ER oral suspension) for ADHD found its extended-release claim supported by biopharm data. Classified as a Schedule II controlled substance, the drug's efficacy was demonstrated in the Phase 3 TRI102-ADD-001 study in pediatric patients. Safety assessments revealed no new safety signals or suicidal ideations.
Key findings — cited to the page
| Subjects with treatment-related psychiatric disorders (open-label) | 33 | TRI102-ADD-001 · p.14 |
| Percentage of subjects with treatment-related psychiatric disorders (open-label) | 30.8 % | TRI102-ADD-001 · p.14 |
| Subjects with treatment-related metabolism and nutrition disorders (open-label) | 28 | TRI102-ADD-001 · p.14 |
| Percentage of subjects with treatment-related metabolism and nutrition disorders (open-label) | 26.2 % | TRI102-ADD-001 · p.14 |
| Subjects with treatment-related gastrointestinal disorders (open-label) | 14 | TRI102-ADD-001 · p.14 |
| Percentage of subjects with treatment-related gastrointestinal disorders (open-label) | 13.1 % | TRI102-ADD-001 · p.14 |
| Subjects with TEAEs (double-blind) | 15 | TRI102-ADD-001 · p.14 |
| Percentage of placebo subjects with TEAEs (double-blind) | 12.5 % | TRI102-ADD-001 · p.14 |
| Drug release at 15 minutes | 65 % | Dyanavel XR · p.5 |
| Dose dumping alcohol level | 40 % | Dyanavel XR · p.5 |
| Controlled Substances Act (CSA) schedule | Schedule II | Dyanavel XR · US · p.5 |
| Percentage of subjects with treatment-related TEAEs (open-label) | 47.7 % | TRI102-ADD-001 · p.14 |
Source: Tris Pharma ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →