Austedo
Neurology· 2386 cited findings· 2 source documents
What the regulatory reviews say
Austedo (deutetrabenazine) is indicated for the treatment of moderate to severe tardive dyskinesia in adults. In a Phase 2/3 trial, Austedo demonstrated a reduction in the AIMS total score of -3.0 points, compared to a -1.6 points reduction in the placebo group, resulting in a treatment effect difference of -1.4 points (p-value 0.0188). This corresponds to a -26.7% reduction in AIMS total score for Austedo versus -15.5% for placebo (p-value 0.0193).
Regarding safety, 59.5% of participants in the deutetrabenazine titration group experienced adverse events, while 53.8% of participants in the placebo group experienced adverse events across trials C-18 and C-23. In trial C-23, 50.0% of participants in the DTBZ 12 mg group, 44.4% in the DTBZ 24 mg group, and 50.0% in the DTBZ 36 mg group experienced adverse events.
The drug's molar mass is 323.462 g/mol. The trial design included a 6-week titration period and a 6-week maintenance period, conducted across 41 centers with a planned enrollment of 92 patients.
Key figures — cited to the source page
| AIMS total score reduction (Austedo) | -3.0 | Teva — Austedo EMA EPAR public assessment report (EMEA/H/C/0, p.90 |
| AIMS total score reduction (placebo) | -1.6 | Teva — Austedo EMA EPAR public assessment report (EMEA/H/C/0, p.90 |
| AIMS total score treatment effect difference | -1.4 | Teva — Austedo EMA EPAR public assessment report (EMEA/H/C/0, p.90 |
| AIMS total score p-value | 0.0188 | Teva — Austedo EMA EPAR public assessment report (EMEA/H/C/0, p.90 |
| Percentage reduction in AIMS total score (Austedo) | -26.7 | Teva — Austedo EMA EPAR public assessment report (EMEA/H/C/0, p.92 |
| Percentage reduction in AIMS total score (placebo) | -15.5 | Teva — Austedo EMA EPAR public assessment report (EMEA/H/C/0, p.92 |
| Percentage of participants with AE in DTBZ Titration group | 59.5 | Teva — Austedo EMA EPAR public assessment report (EMEA/H/C/0, p.195 |
| Percentage of participants with AE in Placebo group | 53.8 | Teva — Austedo EMA EPAR public assessment report (EMEA/H/C/0, p.195 |
Source documents
Explore the full evidence
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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.