Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, enabling it to be utilized as a standalone treatment for patients with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed to be used alongside an oral antidepressant for 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.
“Many patients suffering from difficult-to-treat depression endure lengthy periods trying numerous treatments that fail to alleviate their symptoms, causing significant emotional and functional challenges for both them and their families,” stated Bill Martin, the head of neuroscience at Johnson & Johnson, in a press release.
The application was supported by data from a late-stage clinical trial revealing that Spravato, when used as a standalone treatment, successfully alleviated patients’ symptoms as soon as 24 hours after administration and continued to do so for a minimum of four weeks.
Spravato is delivered via a nasal spray and must be administered under the supervision of a healthcare provider in a clinical environment. In contrast to other antidepressants that focus on regulating neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, the most prevalent neurotransmitter that facilitates 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 2022. The drug has been prescribed to 100,000 individuals across 77 countries, according to Johnson & Johnson.