FDA announcements and press releases

FDA Approves Johnson & Johnson's Ketamine-Derived Spravato Nasal Spray for Treatment-Resistant Depression

Jan 21, 2025, 09:00 PM

The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's nasal spray, Spravato, for use as a standalone treatment for adults with treatment-resistant major depressive disorder (MDD). This approval marks Spravato as the first and only monotherapy for this condition, applicable to patients who have not responded adequately to at least two oral antidepressants. The nasal spray, which is ketamine-derived and contains esketamine, was previously approved in 2019 for use in combination with oral antidepressants. The new approval is based on a phase four trial showing symptom improvement within 24 hours of treatment initiation, lasting up to 28 days. An estimated 21 million U.S. adults suffer from MDD, with about one-third experiencing treatment-resistant depression. Spravato has generated $780 million in sales during the first nine months of 2024 and has been administered to over 140,000 patients worldwide.