The US Food and Drug Administration (FDA) has approved Johnson & Johnson's ketamine-based nasal spray Spravato for the treatment of adults with major depressive disorder, the company announced on Tuesday.
The approval paves the way for the use of Spravato in patients whose illness no longer responds to at least two oral antidepressants.
"Treatment-resistant depression can be very complicated, especially for patients who do not respond to or cannot tolerate oral antidepressants," said J&J's Bill Martin, who leads the company's neuroscience therapy development.
MDD is one of the most common psychiatric disorders.
J&J estimates that approximately 21 million adults in the U.S. live with the disorder.