Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, allowing it to be administered as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for patients who did not see improvement after trying two or more different antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, remarked that many patients struggling with difficult-to-treat depression endure prolonged periods trying various treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for both themselves and their families.
The new application is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, can relieve patient symptoms as quickly as 24 hours after administration and sustain effects for at least four weeks.
Spravato is delivered via nasal spray and must be taken under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that adjust brain chemicals such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuron communication.
In terms of financial performance, sales of Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reports that Spravato has already been utilized by 100,000 patients across 77 countries.