Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, for use as a standalone therapy in patients with treatment-resistant depression.
Spravato received its initial FDA approval in 2019, allowing it to be used in conjunction with an oral antidepressant for patients whose symptoms did not improve after two or more different antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide who suffer 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 submitted to the FDA includes data from a late-stage clinical trial, which indicated that Spravato as a standalone treatment alleviated symptoms in patients as quickly as 24 hours after administration and provided relief for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target brain chemicals such as serotonin and dopamine, Spravato functions by increasing levels of glutamate in the brain, which is the most abundant 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 reported that Spravato has been utilized by 100,000 patients across 77 countries.