J&J seeks FDA approval of Spravato as monotherapy for treatment-resistant depression
Betsy Goodfellow | July 24, 2024 | News story | Medical Communications | J&J, Johnson & Johnson, Neurology, Spravato, treatment-resistant depression
Johnson & Johnson (J&J) has announced that it has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for the approval of Spravato (esketamine) CIII nasal spray as a monotherapy for the treatment of adult patients living with treatment-resistant depression (TRD).
This submission follows positive phase 4 trial results which assessed the efficacy, safety and tolerability of the drug administered as a monotherapy. The randomised, double-blind, multi-centre, placebo-controlled study demonstrated a ‘rapid change in Montgomery-Asberg Depression Rating Scale (MADRS) total score as early as 24 hours after the first Spravato dose, and sustained through at least 4 weeks of treatment’, according to the press release.
The safety profile of the drug as a monotherapy remained consistent with the existing data around it in combination with an oral antidepressant. No new safety concerns were noted.
Bill Martin PhD, global therapeutic area head of neuroscience at J&J Innovative Medicine, 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.”
Betsy Goodfellow
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