Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, as a standalone therapy for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients who did not find relief from two or more antidepressants. Johnson & Johnson indicated that nearly 30 percent of the approximately 280 million individuals globally diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the challenges faced by patients suffering from difficult-to-treat depression, emphasizing that many endure prolonged cycles of ineffective treatments which significantly impact their emotional and daily functioning.
The application to the FDA was supported by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, alleviated symptoms in patients as soon as 24 hours after administration and continued to do so for at least four weeks.
Spravato is delivered as a nasal spray and must be administered in a healthcare setting under professional supervision. Unlike traditional antidepressants that target brain chemicals like serotonin and dopamine, Spravato enhances the activity of glutamate, the brain’s most prevalent neurotransmitter, facilitating neuron communication.
The sales of Spravato surged by 60% to reach $271 million in the three months ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the drug has been utilized by 100,000 patients across 77 countries.