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-derived medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant in patients whose symptoms did not improve with two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide affected by major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the plight of patients enduring difficult-to-treat depression, stating that they often experience prolonged periods of ineffective treatments leading to significant emotional and functional burdens for both patients and their families.
The application is supported by data from a late-stage clinical trial indicating that Spravato, as a standalone therapy, can alleviate symptoms as quickly as 24 hours after administration and remains effective for at least four weeks.
Spravato is delivered as a nasal spray and must be ingested under healthcare supervision in a clinical environment. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter, facilitating communication between neurons.
In the second quarter of 2023, Spravato’s sales surged by 60% to $271 million compared to the same timeframe in the previous year. Johnson & Johnson reported that the drug has been administered to 100,000 patients across 77 countries.