According to Johnson & Johnson, the FDA has approved the company’s sNDA for Spravato esketamine nasal spray as a monotherapy for the treatment of major depressive disorder in adults who have not responded adequately to a minimum of two oral antidepressants. Administration of Spravato is available only in healthcare settings under a REMS program.
Spravato has been approved for use with an oral antidepressant for the treatment of treatment-resistant depression since 2019 and for the treatment of major depressive disorder with acute suicidal ideation or behavior since 2020. J&J submitted the sNDA for Spravato as a monotherapy in July 2024.
Johnson & Johnson Innovative Medicine Global Therapeutic Area Head, Neuroscience, Bill Martin commented, “Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them. For too long, healthcare providers have had few options to offer patients much-needed symptom improvement. Spravato is now available as a standalone treatment, meaning patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days without the need for daily oral antidepressants.”
Read the Johnson & Johnson press release
