Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to allow the use of its ketamine-based medication, Spravato, as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms do not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, highlighted in a press release that “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 for expanded use is backed by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as soon as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is administered as a nasal spray and is required to be taken under the supervision of a healthcare provider in a clinical environment. Unlike other antidepressants that typically target serotonin and dopamine levels in the brain, Spravato enhances glutamate activity. Glutamate is the most prevalent neurotransmitter in the brain and plays a crucial role in neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2023. The medication has been utilized by approximately 100,000 patients across 77 countries, according to Johnson & Johnson.