Spravato(esketamine)
Psychiatry· 2897 cited findings· 4 source documents
Company: Johnson & Johnson →
What the regulatory reviews say
Spravato (esketamine) is indicated, as acute short-term treatment, co-administered with oral antidepressant therapy, for the rapid reduction of depressive symptoms in adult patients with a moderate to severe episode of MDD who have current suicidal ideation with intent. The application for this indication was a Type II group of variations, with Procedure Number EMEA/H/C/004535/II/0001/G.
Efficacy findings include a MADRS total score change from baseline (LS mean treatment difference) for esketamine + SOC vs placebo + SOC of -3.8 and -3.9. Remission of MDD (MADRS total score ≤12) for esketamine + SOC vs placebo + SOC showed treatment differences of 4.8%, 10.6%, 11.4%, and 13.1%. Resolution of suicidality (CGI-SS-R≤1) for esketamine + SOC vs placebo + SOC showed a treatment difference of 13.2%.
Safety data indicates that 89.9% of subjects receiving esketamine + SOC experienced at least one treatment-emergent adverse event (TEAE), compared to 75.6% for placebo + SOC. Common TEAEs included dizziness (38.3% for esketamine + SOC vs 13.8% for placebo + SOC) and dissociation (33.9% for esketamine + SOC vs 5.8% for placebo + SOC). The percentage of subjects with dose reduction due to adverse events or tolerability issues in Phase 3 studies (pooled) was 15.5%. Three suicides were reported in TRD studies.
Key figures — cited to the source page
| MADRS total score change from baseline (LS mean treatment difference) for esketamine + SOC vs placebo + SOC | -3.8 | Johnson & Johnson — Spravato EMA EPAR variation assessment r, p.62 |
| Remission of MDD (MADRS total score ≤12) for esketamine + SOC vs placebo + SOC (treatment difference) | 13.1 | Johnson & Johnson — Spravato EMA EPAR variation assessment r, p.67 |
| Resolution of suicidality (CGI-SS-R≤1) for esketamine + SOC vs placebo + SOC (treatment difference) | 13.2 | Johnson & Johnson — Spravato EMA EPAR variation assessment r, p.69 |
| Percentage of subjects with at least one TEAE (esketamine + SOC) | 89.9% | Johnson & Johnson — Spravato EMA EPAR variation assessment r, p.104 |
| Dizziness incidence (esketamine + SOC) | 38.3% | Johnson & Johnson — Spravato EMA EPAR variation assessment r, p.104 |
| Dissociation incidence (esketamine + SOC) | 33.9% | Johnson & Johnson — Spravato EMA EPAR variation assessment r, p.104 |
| Percentage of subjects with dose reduction due to adverse events or tolerability issues in Phase 3 studies (pooled) | 15.5 | Johnson & Johnson — Spravato EMA EPAR variation assessment r, p.23 |
| Suicides in TRD studies | 3 | Johnson & Johnson — Spravato EMA EPAR variation assessment r, p.134 |
Source documents
- Johnson & Johnson — Spravato FDA Review (NDA211243, ORIG 1, 2019) (2019)
- Johnson & Johnson — Spravato EMA EPAR public assessment report (EMEA/H/C/004535, 2019) (2019)
- Johnson & Johnson — Spravato EMA EPAR variation assessment report (EMEA/H/C/004535, 2019) (2019)
- Johnson & Johnson — Spravato EMA EPAR variation assessment report (EMEA/H/C/004535, 2019) (2019)
Compared with
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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.