Johnson & Johnson announced on Monday that it has applied to the U.S. Food and Drug Administration (FDA) for approval to use its ketamine-based drug, Spravato, as a standalone treatment for individuals suffering from treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was intended to be used in tandem with an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated that many patients enduring difficult-to-treat depression often spend excessive time trying multiple ineffective treatments, which can lead to significant emotional and functional challenges for both the patients and their families.
The application was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, began alleviating patients’ symptoms as soon as 24 hours after administration and continued to do so for a minimum of four weeks.
Spravato is delivered as a nasal spray and must be administered in a healthcare facility under the supervision of a healthcare provider. Unlike traditional antidepressants that primarily target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate, the brain’s most abundant neurotransmitter, plays a crucial role in neuronal communication.
Sales of Spravato increased by 60% to $271 million for the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reports that the drug has been utilized by around 100,000 users across 77 countries.