Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved usage of its ketamine-based medication, Spravato, allowing it 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 whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients endure prolonged suffering as they navigate through various ineffective treatments, leading to significant emotional and functional burdens for both themselves and their families.
The application to the FDA is supported by data from a late-stage clinical trial, which indicated that Spravato, when used alone, began to alleviate patients’ symptoms as quickly as 24 hours after administration and continued to do so for at least four weeks.
Spravato is delivered via a nasal spray and must be consumed in the presence of a healthcare provider within a clinical setting. In contrast to traditional antidepressants that typically influence chemicals such as serotonin and dopamine in the brain, Spravato enhances glutamate levels. Glutamate is the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
In financial terms, sales of Spravato surged by 60%, reaching $271 million during the three months that ended on June 30, compared to the same period in 2022. Johnson & Johnson reports that Spravato has been utilized by 100,000 individuals across 77 countries.