21 January 2024 - Following US FDA priority review, approval is based on data demonstrating Spravato alone met its primary endpoint at 4 weeks and led to rapid and superior improvement in depressive symptoms compared to placebo as early as 24 hours.

Johnson & Johnson announced today the US FDA approval of a supplemental new drug application for Spravato (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive disorder who have had an inadequate response to at least two oral antidepressants.

Read Johnson & Johnson press release