The U.S. Food and Drug Administration (FDA) has expanded its approval for Johnson & Johnson's nasal spray, Spravato, allowing 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 for use in combination with antidepressants in 2019 and was later used for patients experiencing suicidal thoughts and behaviors. report.
Spravato is the “first and only monotherapy for adults with major depressive disorder who have had an inadequate response to at least two oral antidepressants,” Pharmaceutical Giant said Tuesday.
According to Johnson & Johnson, an estimated 21 million adults in the United States have major depressive disorder, one of the most common mental disorders, and one-third do not respond to oral antidepressants alone. , does not interfere with quality of life.
“Treatment-resistant depression can be very complex, especially for patients who do not respond to or cannot tolerate oral antidepressants,” said Bill Therapeutic Area Director, Neuroscience Department at Johnson & Johnson Innovative Medicine. Bill Martin said in a statement.
new york post report Patients may experience improvement in 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 nearly six years of real-world evidence.
As of Tuesday, it had been administered to more than 140,000 patients around the world.
Spravato is intended to be administered under the direct supervision of a healthcare provider.
