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FDA Approves Johnson & Johnson's Spravato as First-Ever Monotherapy for Treatment-Resistant Depression Affecting 21 Million US Adults
Jan 21, 2025, 02:59 PM
The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's nasal spray, Spravato, as a standalone treatment for adults with treatment-resistant major depressive disorder (MDD). This approval marks Spravato as the first-ever monotherapy for this condition, which affects an estimated 21 million U.S. adults. Previously, Spravato was approved for use in combination with oral antidepressants. The drug, which contains esketamine, a derivative of ketamine, has been administered to over 140,000 patients worldwide and has shown to improve depressive symptoms within 24 hours of treatment, lasting at least one month. The approval is based on a phase four trial, and Spravato is on track to become a blockbuster product, with sales reaching $780 million in the first nine months of 2024.
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