Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved usage of its ketamine-based drug, Spravato, to allow it to be used as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for individuals who did not respond to two or more other antidepressants. According to Johnson & Johnson, approximately 30 percent of the 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, stated in a press release that “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 to the FDA includes data from a late-stage clinical trial, which indicated that Spravato, when administered as a standalone treatment, showed improvement in patients’ symptoms as early as 24 hours after treatment and sustained relief for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that affect serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and facilitates neuron communication.
Sales of Spravato increased by 60% to $271 million in the quarter that ended on June 30, compared to the same period in 2023, with the treatment being used by 100,000 individuals across 77 countries, according to the company.