J&J’s Spravato first approval as monotherapy for treatment-resistant depression

21 January 2025

US healthcare giant Johnson & Johnson (NYSE: JNJ) announced the US Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Spravato (esketamine) CIII nasal spray as the first and only monotherapy for adults with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants.

J&J noted that MDD is one of the most common psychiatric disorders, with an estimated 21 million adults in the U.S. living with the disease. About one-third of adults will not respond to oral antidepressants alone, which has a significant negative impact on the quality of life of those affected.

The FDA approved Spravato CIII nasal spray, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression in adults on March 5, 2019. In the third-quarter of 2024 the drug achieved sales of $284 million, up 54.9%year-on-year.

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