FDA official announcements and approvals

FDA Approves Johnson & Johnson's Spravato as First Standalone Nasal Spray Treatment for Depression, Sales at $780 Million

Jan 21, 2025, 01:22 PM

The U.S. Food and Drug Administration has approved Johnson & Johnson's nasal spray, Spravato (esketamine), as a standalone treatment for adults with treatment-resistant major depressive disorder (MDD). This approval marks Spravato as the first therapy of its kind, allowing it to be used without the need for an accompanying oral antidepressant. Previously, Spravato was only approved for use in conjunction with an oral antidepressant for treatment-resistant depression and for individuals with major depressive disorder experiencing suicidal thoughts. The drug, which entered the U.S. market in 2019, has shown to improve depressive symptoms within 24 hours of treatment, with effects lasting at least one month. Johnson & Johnson reported that Spravato generated $780 million in sales during the first nine months of 2024, with expectations for annual sales to reach between $1 billion and $5 billion. This growth is supported by its administration in 3,000 certified treatment centers across the U.S., indicating its growing acceptance among doctors and potential to become a blockbuster product. The approval comes at a time when around 21 million U.S. adults suffer from major depression, highlighting the need for effective treatment options.