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.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant, aimed at patients whose symptoms failed to improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted in a press release that “many patients dealing with difficult-to-treat depression endure prolonged periods trying multiple treatments that do not effectively alleviate their symptoms, creating significant emotional and functional burdens for them and their families.”
The application to the FDA is supported by data from a late-stage clinical trial, which indicated that Spravato as a standalone treatment showed a reduction in patients’ symptoms as quickly as 24 hours after treatment 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 modulate neurotransmitters such as serotonin and dopamine, Spravato enhances the levels of glutamate in the brain, the most prevalent neurotransmitter that facilitates communication between neurons.
Sales of Spravato increased significantly, soaring by 60% to reach $271 million in the three months ending June 30, compared to the same period in 2022. Johnson & Johnson reports that over 100,000 individuals in 77 countries have utilized Spravato.