Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be administered as a standalone therapy for individuals with treatment-resistant depression.
Spravato was first authorized by the FDA in 2019 for use in conjunction with an oral antidepressant for those who did not experience improvement from two or more antidepressant treatments.
The company highlighted that nearly 30 percent of the estimated 280 million people globally living with major depressive disorder suffer from treatment-resistant depression.
“Many patients with difficult-to-treat depression endure lengthy periods trying multiple treatments that fail to alleviate their symptoms, leading to significant functional and emotional challenges for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, demonstrated the ability to alleviate symptoms as early as 24 hours post-treatment, maintaining effectiveness for at least four weeks.
Spravato is administered via a nasal spray and must be taken under the supervision of a healthcare professional in a clinical environment. Unlike conventional antidepressants that target chemicals like serotonin and dopamine, Spravato increases glutamate levels in the brain, which plays a crucial role in neuronal communication.
In terms of sales, Spravato’s revenue surged by 60%, reaching $271 million in the three months ending June 30, compared to the same quarter in 2023. According to Johnson & Johnson, the medication has been utilized by 100,000 individuals across 77 countries.