Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-derived medication, Spravato, for use as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019, but only for use alongside an oral antidepressant for patients who did not respond to two or more antidepressant treatments.
According to Johnson & Johnson, nearly 30% of the 280 million people worldwide affected by major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, stated that many individuals battling difficult-to-treat depression often spend extended periods trying multiple treatments that fail to alleviate their symptoms, resulting in significant emotional and functional challenges for both patients and their families.
The application to the FDA includes data from a late-stage clinical trial demonstrating that Spravato, when used alone, showed the ability to reduce patients’ symptoms as soon as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that affect neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, a neurotransmitter crucial for neuronal communication.
In the three months ending June 30, sales of Spravato increased by 60% to $271 million compared to the same period in 2023. The drug has been utilized by approximately 100,000 individuals across 77 countries, as reported by Johnson & Johnson.