Tris Pharma — Dyanavel Xr FDA Review (NDA210526, ORIG 1, 2021)
Tris Pharma · 2021 · FDA Review (openFDA)
Report summary
Tris Pharma's Dyanavel XR (amphetamine extended-release tablets) for ADHD in patients aged 6 and older faced a challenging FDA approval process. Despite clinical and biopharmaceutics teams recommending approval based on bioequivalence to the existing oral suspension and a favorable nonclinical safety profile, the application received multiple complete response letters. These delays stemmed primarily from manufacturing facility deficiencies and an Official Action Indicated (OAI) status. While no new efficacy data was presented for the tablet, its safety profile was deemed similar to the oral suspension, with no new significant safety signals. Approval was ultimately granted after manufacturing issues were resolved and an enhanced pharmacovigilance plan for potential serious gastrointestinal adverse events was implemented. Post-marketing commitments include pediatric studies for 4-5 year olds.
Key findings — cited to the page
| Incidence of dizziness (Treatment B) | 0 % | Study 2016-4171 · p.58 |
| Incidence of dizziness (Treatment C) | 6 % | Study 2016-4171 · p.58 |
| Incidence of dizziness (Treatment D) | 0 % | Study 2016-4171 · p.58 |
| Maximum QTcB value | 480 msec | Study 2016-4171 · p.59 |
| Amount of SPS in largest tablet (20mg) | 88 mg | · p.60 |
| Amount of mannitol in largest tablet (20mg) | 429 mg | · p.60 |
| REMS requirement | not required | · p.63 |
| NDA number | 210526 | DYANAVEL XR (amphetamine) extended-release tablets · p.2 |
| PDUFA Goal Date | November 4, 2021 | · p.2 |
| Proposed Indication | Treatment of Attention Deficit Hyperactivity Disorder (ADHD) | DYANAVEL XR (amphetamine) extended-release tablets · p.2 |
| Recommendation | Approval | DYANAVEL XR (amphetamine) extended-release tablets · p.2 |
| Trial enrollment | 16 healthy adults | 2016-4009 · p.54 |
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 →