Johnson & Johnson — Spravato EMA EPAR variation assessment report (EMEA/H/C/004535, 2019)
Johnson & Johnson · 2019 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the assessment of Spravato (esketamine) for adolescents with major depressive disorder (MDD) at imminent risk of suicide. The primary study, ESKETINSUI2002, evaluated intranasal esketamine (28 mg, 56 mg, 84 mg) plus standard of care. Pooled 56 mg and 84 mg doses demonstrated a statistically significant improvement in depressive symptoms (CDRS-R total score) at 24 hours post-first dose compared to psychoactive placebo (midazolam). While individual higher doses weren't significant, a rapid reduction in symptoms was observed. The safety profile was consistent with adult studies, with no new safety signals, despite a high incidence of treatment-emergent adverse events. Midazolam was used as a psychoactive placebo to maintain blinding due to esketamine's observable effects.
Key findings — cited to the page
| Anxiety | 19.3% | ESKETINSUI2002 · p.23 |
| Anxiety | 23.8% | ESKETINSUI2002 · p.23 |
| TEAEs potentially related to suicidality | 31.3% | ESKETINSUI2002 · p.23 |
| TEAEs potentially related to suicidality | 27.0% | ESKETINSUI2002 · p.23 |
| Suicide attempt (serious TEAE) | 8.4% | ESKETINSUI2002 · p.23 |
| Suicide attempt (serious TEAE) | 7.9% | ESKETINSUI2002 · p.23 |
| Suicidal ideation (serious TEAE) | 6.0% | ESKETINSUI2002 · p.23 |
| Suicidal ideation (serious TEAE) | 4.8% | ESKETINSUI2002 · p.23 |
| patients with treatment-emergent adverse event (double-blind phase) | 96.4 % | · p.25 |
| participants with at least 1 TEAE (esketamine 56 mg + SOC group) | 96.8 % | · p.25 |
| Procedure number | EMEA/H/C/004535/P46/005 | Spravato · p.1 |
| discontinuations for safety reasons | 0 | · p.25 |
Source: Johnson & Johnson ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →