Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who did not experience improvement after trying two or more antidepressants. Johnson & Johnson reported that nearly 30% of the approximately 280 million individuals worldwide suffering from major depressive disorder have treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, expressed in a press release that many patients with difficult-to-treat depression often endure lengthy periods trying multiple therapies that do not effectively alleviate their symptoms, resulting in significant emotional and functional burdens for both the patients and their families.
The application was supported by data from a late-stage clinical trial indicating that Spravato, when used alone, began to relieve patients’ symptoms as soon as 24 hours after treatment and continued to do so for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike other antidepressants that target brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most plentiful neurotransmitter and facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. According to Johnson & Johnson, Spravato has been administered to 100,000 individuals across 77 countries.