Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be prescribed as a standalone therapy for treatment-resistant depression.
The FDA initially authorized Spravato in 2019 as a complementary treatment alongside an oral antidepressant for individuals whose depression symptoms failed to improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The application includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can alleviate symptoms as soon as 24 hours after administration and maintain effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that influence serotonin and dopamine levels in the brain, Spravato enhances the activity of glutamate, which is the most prevalent neurotransmitter in the brain and plays a critical role in neuronal communication.
Sales of Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same timeframe in 2023. The medication has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.