Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based medication, Spravato, to function as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 to be used alongside an oral antidepressant for patients who did not see improvement after trying two or more traditional antidepressants.
Johnson & Johnson stated that around 30 percent of the approximately 280 million individuals globally diagnosed with major depressive disorder experience treatment-resistant depression.
“Many patients struggling with difficult-to-treat depression often go through numerous treatments that fail to alleviate their symptoms, resulting in significant emotional and functional challenges for them and their families,” said Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The submission was backed by data from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, showed a reduction in symptoms as quickly as 24 hours post-treatment and maintained effectiveness for at least four weeks.
Spravato is administered as a nasal spray and requires administration under the supervision of a healthcare provider. Unlike conventional antidepressants, which target brain chemicals like serotonin and dopamine, Spravato enhances the action of glutamate, the brain’s most prevalent neurotransmitter, facilitating neuronal communication.
Sales for Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2022. The medication has been utilized by approximately 100,000 patients across 77 countries, according to Johnson & Johnson.