The expanded indication allows esketamine nasal spray to be used as a standalone treatment in adults with MDD who have not responded to at least two oral antidepressants.

Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the standalone treatment of major depressive disorder (MDD), PTSD, and similar psychiatric conditions.

Spravato is now the first stand-alone therapy for treatment-resistant depression, for patients who haven’t responded to oral antidepressants. On Tuesday, the Food and Drug Administration (FDA) approved Johnson & Johnson’s nasal spray,