Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, to serve as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019, designed to be used in conjunction with an oral antidepressant for individuals whose depression did not improve after trying two or more other antidepressants.
According to Johnson & Johnson, approximately 30% of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized that many patients enduring difficult-to-treat depression often spend excessive time cycling through various treatments that fail to alleviate their symptoms, which can place a significant emotional and functional strain on both the patients and their families.
The application for expanded use is supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, could alleviate symptoms as soon as 24 hours after administration and maintain those effects for at least four weeks.
Administered as a nasal spray, Spravato must be taken in a healthcare setting under the supervision of a provider. Unlike traditional antidepressants that adjust neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales figures for Spravato saw significant growth, rising by 60% to $271 million in the quarter ending June 30, 2023, compared to the same period the previous year. To date, the drug has been used by over 100,000 individuals across 77 countries, as reported by Johnson & Johnson.