FDA Approves First Nasal Spray for Treatment-Resistant Depression

Johnson & Johnson's Spravato becomes the first standalone therapy for adults with major depressive disorder who have not responded to oral antidepressants.

Spravato, derived from esketamine, is the first FDA-approved monotherapy for treatment-resistant depression, offering rapid symptom relief within 24 hours.
The approval follows a phase 4 trial showing significant improvements in depressive symptoms compared to a placebo, sustained for at least 28 days.
Spravato targets the brain's glutamate system, differing from traditional antidepressants, though its exact mechanism remains unclear.
The treatment is only available through a restricted program in certified healthcare settings due to potential side effects like sedation, dissociation, and respiratory issues.
Over 140,000 patients have already received Spravato worldwide, and Johnson & Johnson projects annual sales of $1 billion to $5 billion.