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 medication, Spravato, as a standalone therapy for treatment-resistant depression.
Spravato received its initial FDA approval in 2019, intended for use alongside an oral antidepressant for patients whose symptoms remained unresolved after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million people globally diagnosed with major depressive disorder experience treatment-resistant depression.
“Many patients with hard-to-treat depression often endure long periods of trying various treatments that fail to alleviate their symptoms, resulting in considerable functional and emotional strain on both patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application was supported by data from a late-stage clinical trial indicating that Spravato, when used alone, alleviated symptoms as quickly as 24 hours after the initial treatment and continued to be effective for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants, which typically target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate, the predominant neurotransmitter, plays a key role in neuron communication.
Sales of Spravato increased by 60%, reaching $271 million in the three-month period ending June 30, compared to the same period in 2023. Johnson & Johnson reports that the medication has been utilized by 100,000 individuals across 77 countries.