Johnson & Johnson said that it has submitted an sNDA to the FDA for the use of Spravato esketamine CIII nasal spray as a monotherapy for the treatment of treatment-resistant depression. In 2019, the FDA approved an NDA submitted by J&J subsidiary Janssen Pharmaceuticals (now Johnson & Johnson Innovative Medicine) for the use of Spravato with an oral antidepressant for treatment-resistant depression. The nasal spray has also been approved in the US for the treatment of major depressive disorder with acute suicidal ideation or behavior, along with an oral antidepressant, since 2020.
The company said that the sNDA includes results from the Phase 4 TRD4005 study of Spravato as a monotherapy. The company says that in that trial Spravato demonstrated rapid improvement in depression symptoms as soon as 24 hours after the initial dose, with the improvement lasting during treatment periods of at least 4 weeks.
Johnson & Johnson Innovative Medicine Global Therapeutic Area Head, Neuroscience, Bill Martin commented, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones. We’re pleased to build on the more than a decade of research reinforcing the safety and efficacy of Spravato and look forward to working with the FDA to bring this innovative treatment to patients as a monotherapy option.”
Read the Johnson & Johnson press release.
