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FDA approves Spravato nasal spray as standalone treatment for treatment-resistant depression.
The FDA has approved Johnson & Johnson's nasal spray, Spravato, as a standalone treatment for adults with major depressive disorder who have not responded to at least two other antidepressants.
This is the first such standalone treatment for treatment-resistant depression.
Approved initially in 2019 for use with oral antidepressants, Spravato is now shown to provide significant symptom relief within 24 hours on its own, without daily oral medication.
The drug, derived from ketamine, must be administered in certified healthcare settings due to potential serious side effects.
Over 20 million adults in the U.S. have major depressive disorder, with about one-third not responding to oral antidepressants alone.
La FDA aprueba el spray nasal de Spravato como tratamiento independiente para la depresión resistente al tratamiento.