Dyanavel XR
Psychiatry· 175 cited findings· 2 source documents
Company: Tris Pharma
What the regulatory reviews say
Dyanavel XR is an extended-release amphetamine tablet proposed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The duration of clinical efficacy for Amphetamine ER tablets ranges from one hour to 13 hours after dosing. Bioequivalence studies comparing the tablet to a suspension formulation showed d-AMP Cmax geometric mean ratio of 102.5% and l-AMP Cmax geometric mean ratio of 102.1%.
Safety findings include a maximum QTcB value of 480 msec. The largest 20mg tablet contains 88 mg of SPS and 429 mg of mannitol. Carcinogenicity studies in male mice used a dose of 30 mg/kg/day, which is 4 times the multiple vs MRHD. The manufacturing site status is voluntary action indicated (VAI).
The FDA review recommends approval for Dyanavel XR (NDA 210526), with a PDUFA Goal Date of November 4, 2021. A Risk Evaluation and Mitigation Strategy (REMS) is not required for this drug.
Key figures — cited to the source page
| Duration of clinical efficacy for Amphetamine ER tablets | one hour to 13 hours | Tris Pharma — Dyanavel Xr FDA Review (NDA210526, ORIG 1, 202, p.32 |
| d-AMP Cmax geometric mean ratio (tablet vs suspension) | 102.5 % | Tris Pharma — Dyanavel Xr FDA Review (NDA210526, ORIG 1, 202, p.49 |
| l-AMP Cmax geometric mean ratio (tablet vs suspension) | 102.1 % | Tris Pharma — Dyanavel Xr FDA Review (NDA210526, ORIG 1, 202, p.49 |
| Maximum QTcB value | 480 msec | Tris Pharma — Dyanavel Xr FDA Review (NDA210526, ORIG 1, 202, p.59 |
| Carcinogenicity dose multiple vs MRHD (male mice) | 4 times | Tris Pharma — Dyanavel Xr FDA Review (NDA210526, ORIG 1, 202, p.40 |
| REMS requirement | not required | Tris Pharma — Dyanavel Xr FDA Review (NDA210526, ORIG 1, 202, p.63 |
| Recommendation | Approval | Tris Pharma — Dyanavel Xr FDA Review (NDA210526, ORIG 1, 202, p.2 |
| PDUFA Goal Date | November 4, 2021 | Tris Pharma — Dyanavel Xr FDA Review (NDA210526, ORIG 1, 202, p.2 |
Source documents
Explore the full evidence
All 175 cited findings for Dyanavel XR — searchable, comparable and answerable in plain language — are in the Psychiatry research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.