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 function as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 as a treatment to be used alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 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 for expanded use was based on data from a late-stage clinical trial revealing that Spravato, when used alone, alleviated patients’ symptoms as early as 24 hours after administration and provided relief for at least four weeks.
Spravato is delivered as a nasal spray and needs to be taken under the supervision of a healthcare provider in a controlled setting. Unlike other antidepressants that work by influencing chemicals like serotonin and dopamine, Spravato increases levels of glutamate in the brain. Glutamate is the most prevalent neurotransmitter in the brain, facilitating communication between neurons.
Sales figures for Spravato reflected a significant increase, with a 60% rise to $271 million for the quarter 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.