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, to allow it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms did not improve with multiple antidepressant therapies. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals globally diagnosed with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the challenges faced by patients dealing with hard-to-treat depression, noting that they often endure prolonged periods trying ineffective treatments, which can place a significant emotional and functional strain on both themselves and their families.
The new application is supported by data from a late-stage clinical trial showing that Spravato, when used as a standalone therapy, alleviated patients’ symptoms within 24 hours of treatment and continued to do so for at least four weeks.
Spravato is delivered via a nasal spray and must be administered under medical supervision in a healthcare facility. Unlike conventional antidepressants that alter neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
In the quarter ending June 30, sales of Spravato surged by 60% to $271 million compared to the same period in 2023, with approximately 100,000 individuals in 77 countries using the medication, as stated by Johnson & Johnson.