The U.S. Food and Drug Administration (FDA) has expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for millions of U.S. patients dealing with severe depression.
The ketamine-derived drug was first approved in 2019 to be used in combination with antidepressants, and later for patients experiencing suicidal thoughts or actions, Reuters reports.
Spravato is “the first and only monotherapy for adults living with major depressive disorder who have had an inadequate response to at least two oral antidepressants,” the pharmaceutical giant said Tuesday.
An estimated 21 million adults in the U.S. are living with major depressive disorder, one of the most common psychiatric disorders, but one-third of them will not respond to oral antidepressants alone, hindering their quality of life, according to Johnson & Johnson.
“Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them. For too long, healthcare providers have had few options to offer patients much-needed symptom improvement,” Bill Martin, global therapeutic area head of Neuroscience at Johnson & Johnson Innovative Medicine, said in a statement.
The New York Post reports patients could experience improvements in their symptoms as early as 24 hours without the need for daily oral antidepressants.
The approval, granted following FDA priority review, comes after more than a decade of research and almost six years of real-world evidence.
As of Tuesday, it has been administered to more than 140,000 patients worldwide.
Spravato is intended to be administered under the direct supervision of a healthcare provider.
