Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use alongside an oral antidepressant for patients who experienced no improvement after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide living with major depressive disorder struggle with treatment-resistant depression.
“Many patients with difficult-to-treat depression endure prolonged periods of trying multiple treatments that fail to alleviate their symptoms, leading to significant emotional and functional burdens for both themselves and their families,” stated Bill Martin, the head of neuroscience at Johnson & Johnson, in a press release.
The application includes findings from a late-stage clinical trial demonstrating that Spravato, when administered as a standalone treatment, alleviated symptoms in patients as early as 24 hours after treatment and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target brain chemicals such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and is essential for communication between neurons.
Sales of Spravato surged by 60% to $271 million during the three months ending June 30, compared to the same period in 2023. Johnson & Johnson reports that the medication has been utilized by 100,000 patients across 77 countries.