Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to allow its ketamine-based medication, Spravato, to be used as a standalone treatment for 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 see improvement after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the 280 million individuals worldwide with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients with difficult-to-treat depression often endure prolonged periods trying various treatments that fail to alleviate their symptoms, leading to considerable functional and emotional distress for both patients and their families.
The submission for FDA approval is based on data from a late-stage clinical trial that indicated Spravato, when used as a standalone therapy, could reduce symptoms in patients as soon as 24 hours after the first treatment and continue to do so for at least a month.
Spravato is administered as a nasal spray and must be given under the supervision of a healthcare professional in a clinical setting. Rather than affecting neurotransmitters like serotonin and dopamine as traditional antidepressants do, Spravato increases levels of glutamate in the brain. Glutamate is the primary neurotransmitter responsible for neuron communication.
Sales for Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same period in 2022. According to Johnson & Johnson, Spravato has been utilized by 100,000 patients across 77 countries.