Johnson & Johnson — Spravato FDA Review (NDA211243, ORIG 1, 2019)
Johnson & Johnson · 2019 · FDA Review (openFDA) · company profile →
Report summary
This FDA clinical review recommends approval for Johnson & Johnson's Spravato (esketamine) for treatment-resistant depression (TRD) in adults. Spravato, an intranasal NMDA receptor antagonist, demonstrated efficacy in two Phase 3 studies (3002 and 3003), showing statistically significant improvement in MADRS scores and longer time to relapse. Safety concerns include dissociation, sedation, hypertension, bladder toxicity, and abuse potential, leading to a required REMS plan for administration in medically supervised settings. Postmarketing studies are recommended for long-term effects and monotherapy. The review also details clinical trial designs, endpoints, and safety profiles, including adverse events like suicidal ideation and increased TSH levels.
Key findings — cited to the page
| Annual prevalence of ketamine use among 12th graders in 2000 | 2.5 % | · p.235 |
| Annual prevalence of ketamine use among 12th graders in 2017 | 1.2 % | · p.235 |
| Number of investigators with proprietary interest in the product tested | 0 | · p.284 |
| Number of investigators with compensation influenced by study outcome | 0 | · p.284 |
| Application Number | 211243 | Spravato (Esketamine) · p.2 |
| Patients experiencing sedation | 49 to 61 % | · p.236 |
| Placebo patients experiencing sedation or dissociation | 23 % or less | · p.236 |
| Patients experiencing dissociation | 60 to 79 % | · p.236 |
| Dissociation change >4 in Study 3002 (Placebo) | 16 (15%) | · p.228 |
| Number of investigators who are sponsor employees | 2 | · p.284 |
| Number of investigators with disclosable financial interests/arrangements | 3 | · p.284 |
| Dissociation change >4 in Study 3001 (Esketamine 84 mg) | 83 (72%) | · p.228 |
Source: Johnson & Johnson ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →