Johnson & Johnson — Spravato EMA EPAR public assessment report (EMEA/H/C/004535, 2019)

Johnson & Johnson · 2019 · EMA EPAR public assessment report · company profile →

Report summary

The EMA's assessment of Spravato (esketamine) for treatment-resistant depression (TRD) highlights its efficacy as an add-on therapy, demonstrating significant reductions in depressive symptoms and relapse prevention in clinical trials. While an accelerated assessment was declined, the report details robust pharmaceutical development, non-clinical data, and extensive clinical trials (Phase 2 and 3) supporting its mechanism as an NMDAR modulator. Safety concerns include transient dissociation, dizziness, nausea, and blood pressure increases, necessitating post-administration monitoring and risk mitigation. Despite a higher incidence of adverse events in Japanese subjects, the overall benefit-risk balance was deemed positive, leading to a recommendation for marketing authorization with specific risk minimization measures.

Key findings — cited to the page

NOEC Daphnia sp. Reproduction Test	98.8 µg/L	· p.31
Subjects with history of anxiety disorder in TRD3001	12.3% %	TRD3001 · p.67
MADRS total score for stable remission	<=12	· p.60
Subjects with family history of depression	41% to 63% %	· p.67
Subjects with family history of depression in TRD3001	62.9% %	TRD3001 · p.67
Subjects with history of alcohol abuse in TRD3001	17.5% %	TRD3001 · p.67
PHQ-9 total score improvement for response	>=50% %	· p.61
MADRS total score improvement for response	>=50% %	· p.61
SDS score for response	<=4	· p.61
Subjects with markedly ill CGI-S score in TRD3001	57.3% %	TRD3001 · p.67
Mean age of subjects in TRD3001	46.3 years	TRD3001 · p.67
Mean age of subjects in TRD3005	70.0 years	TRD3005 · p.68

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 →