FDA Approves Johnson & Johnson's Spravato Nasal Spray as First and Only Standalone Treatment for Treatment-Resistant Major Depressive Disorder

Jan 21, 2025, 07:02 PM

The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's nasal spray, Spravato (esketamine), as the first and only standalone treatment for adults suffering from treatment-resistant major depressive disorder (MDD). Previously, Spravato was authorized for use in conjunction with other antidepressants. This new approval allows the nasal spray to be administered to patients who have not responded adequately to at least two oral antidepressants. Johnson & Johnson's announcement highlights that over 140,000 patients have received Spravato worldwide, supported by nearly six years of real-world data. The approval marks a significant advancement in the treatment options available for individuals facing severe depression, as the FDA's decision comes amidst growing sales of the drug.