Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Spravato was first authorized by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more different antidepressants.
According to Johnson & Johnson, approximately 30 percent of the estimated 280 million people worldwide affected by major depressive disorder experience treatment-resistant depression.
“Many patients facing difficult-to-treat depression often spend excessive time trying multiple treatments that fail to alleviate their symptoms, leading to significant emotional and functional burdens for themselves and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application is supported by data from a late-stage clinical trial indicating that Spravato, when administered alone, began alleviating patients’ symptoms as soon as 24 hours after treatment and continued to do so for at least four weeks.
Spravato is provided as a nasal spray and requires administration under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily affect brain chemicals such as serotonin and dopamine, Spravato operates by increasing levels of glutamate in the brain. Glutamate, recognized as the most prevalent neurotransmitter, plays a vital role in neuron communication.
Sales of Spravato surged by 60% to $271 million during the three months ending June 30, compared to the same quarter in 2023. The medication has been utilized by 100,000 patients across 77 countries, according to the company.