Johnson & Johnson announced on Monday that it has applied to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing 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 who did not experience improvement after trying two or more other antidepressants.
According to Johnson and Johnson, nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder face 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.”
This application was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as soon as 24 hours after administration and maintained this effect for a minimum of four weeks.
Spravato is delivered via a nasal spray and must be taken under the supervision of a healthcare professional in a medical facility. Unlike typical antidepressants that modify brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter in the brain and plays a crucial role in neuronal communication.
Sales of Spravato surged 60% to $271 million during the quarter ending on June 30, compared to the same period in 2023. The drug has been administered to 100,000 individuals across 77 countries, according to Johnson & Johnson.