Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the approval of its ketamine-based medication, Spravato, for use as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019, but only as a supplementary treatment alongside an oral antidepressant for patients who had not experienced improvements after using two or more antidepressants.
According to Johnson & Johnson, nearly 30% of the approximately 280 million individuals worldwide diagnosed with major depressive disorder suffer from treatment-resistant depression.
“Many patients facing difficult-to-treat depression endure lengthy periods of trying multiple treatments that fail to improve their symptoms, leading to significant emotional and functional challenges for both them and their families,” stated Bill Martin, Head of Neuroscience at Johnson & Johnson, in a press release.
The new application is based on data from a late-stage clinical trial that indicated Spravato as a standalone treatment could alleviate patients’ symptoms within 24 hours and maintain effectiveness 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 traditional antidepressants that alter the levels of serotonin and dopamine in the brain, Spravato enhances glutamate activity. Glutamate is the primary neurotransmitter in the brain, facilitating communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson noted that Spravato has been utilized by 100,000 patients across 77 countries.