Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms had not improved after trying two or more antidepressants. According to Johnson & Johnson, approximately 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder struggle with treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, expressed the significant emotional and functional burdens that patients with hard-to-treat depression face, often exhausting multiple treatments without relief.
The recent application is supported by data from a late-stage clinical trial demonstrating that Spravato can alleviate patients’ symptoms as quickly as 24 hours post-treatment and sustain improvements for at least four weeks.
Administered as a nasal spray, Spravato must be used under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target serotonin and dopamine, Spravato enhances glutamate levels in the brain, a neurotransmitter that facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same period in 2023. According to Johnson & Johnson, the medication has been utilized by 100,000 patients across 77 countries.