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 EMA assessment report evaluates a variation application for Spravato (esketamine) nasal spray to treat moderate to severe Major Depressive Disorder (MDD) with suicidal ideation (MDSI). Clinical trials (SUI3001, SUI3002) demonstrated esketamine's rapid reduction of depressive symptoms within 24 hours, a significant unmet medical need. However, it did not show a statistically significant effect on suicidality measures. The safety profile was consistent with previous findings in treatment-resistant depression, with common adverse events including dizziness, dissociation, and increased blood pressure. While efficacy in preventing suicide was not proven, the indication was revised to reflect its rapid antidepressant effect. Risk minimization measures emphasize supervised administration and patient monitoring.
Key findings — cited to the page
| Number of subjects in SUI3001 (Placebo + SOC arm) | 112 | SUI3001 · p.20 |
| Percentage of subjects in safety analysis set receiving one or more medications of special interest prior to enrolment (SUI3002) | 95.6 % | ASPIRE II (SUI3002) · p.60 |
| Mean duration of initial hospitalization for SOC + esketamine group (SUI3002) | 21.6 | ASPIRE II (SUI3002) · p.60 |
| Suicides in TRD studies | 3 | · p.134 |
| Procedure Number | EMEA/H/C/004535/II/0001/G | Spravato · p.1 |
| Application Type | Type II group of variations | · p.7 |
| Proposed new therapeutic indication | 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. | Spravato · p.12 |
| Paediatric clinical studies planned for adolescents with MDSI | 3 | esketamine · p.9 |
| Estimated completion time for paediatric program | 8 years | esketamine · p.9 |
| Subjects randomized in ongoing Phase 2 proof-of-concept study | one-half of the planned 145 subjects | esketamine · p.9 |
| Number of subjects in SUI3001 (Esketamine + SOC arm) | 112 | SUI3001 · p.20 |
| Number of subjects in SUI3002 (Esketamine + SOC arm) | 114 | SUI3002 · p.20 |
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 →