Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for patients with treatment-resistant depression.
The FDA first approved Spravato in 2019 for use in conjunction with an oral antidepressant for patients who showed no improvement after trying two or more antidepressants.
Johnson & Johnson noted that nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Many patients facing difficult-to-treat depression endure prolonged periods trying numerous treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The submission includes data from a late-stage clinical trial indicating that Spravato, when used alone, effectively alleviated patients’ symptoms within 24 hours of treatment, sustaining improvement for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that primarily target neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and plays a critical role in neuronal communication.
In the second quarter of 2023, Spravato sales surged by 60%, reaching $271 million compared to the same quarter last year. To date, Spravato has been prescribed to 100,000 individuals across 77 countries, according to Johnson & Johnson.