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, so that it can be utilized as a standalone treatment for individuals with treatment-resistant depression.
The FDA initially approved Spravato in 2019, allowing its use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally suffering from major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression often spend excessive time trying various treatments that fail to alleviate their symptoms, leading to a significant emotional and functional burden for both themselves and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application to the FDA was supported by data from a late-stage clinical trial that demonstrated Spravato, when used as a standalone therapy, provided symptom relief for patients as soon as 24 hours after treatment, with effects lasting for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare professional in a suitable medical environment. Unlike other antidepressants that modify chemicals such as serotonin and dopamine, Spravato increases levels of glutamate in the brain. Glutamate is the most prevalent neurotransmitter in the brain, playing a crucial role in neuron communication.
Sales of Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same period in 2023. According to Johnson & Johnson, Spravato has been utilized by 100,000 people across 77 countries.