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FDA Approves Johnson & Johnson's ($JNJ) Ketamine-Derived Spravato as Standalone Treatment for 21 Million US Adults with Treatment-Resistant Depression
Jan 21, 2025, 06:21 PM
The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's ($JNJ) 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-ever monotherapy for this condition, which affects an estimated 21 million US adults who have not responded to at least two oral antidepressants. Previously, the ketamine-derived drug was approved for use in combination with oral antidepressants for treatment-resistant depression and for those with MDD experiencing suicidal thoughts. Spravato, which contains esketamine, has been administered to over 140,000 patients worldwide and has generated $780 million in sales during the first nine months of 2024. The approval is based on a phase four trial demonstrating that Spravato alone can improve depressive symptoms within 24 hours and maintain relief for at least one month.
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