Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to extend the usage of its ketamine-based medication, Spravato, allowing it to be used as a standalone therapy for treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant for patients whose symptoms remained unchanged after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 is backed by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, provided relief from symptoms as early as 24 hours after administration and sustained improvement for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical environment. Unlike typical antidepressants that target neurotransmitters like serotonin and dopamine, Spravato increases levels of glutamate in the brain. Glutamate is the brain’s most prevalent neurotransmitter and plays a crucial role in neuron communication.
Sales of Spravato increased by 60% to $271 million during the three months ending June 30, compared to the same period in 2023. Johnson & Johnson reports that the drug has been utilized by 100,000 patients across 77 countries.