Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
The FDA granted its initial approval for Spravato in 2019, permitting its use alongside an oral antidepressant for patients who had not seen improvement after trying two or more different antidepressant medications.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals globally suffering from major depressive disorder experience treatment-resistant depression. Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression, noting that they often endure prolonged periods of ineffective treatments, leading to significant emotional and functional strain.
The application submitted to the FDA includes data from a late-stage clinical trial indicating that Spravato, when used alone, significantly alleviated patients’ symptoms within 24 hours of treatment and sustained that relief for at least four weeks.
Spravato is delivered via a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that adjust brain chemicals like serotonin and dopamine, Spravato enhances the availability of glutamate in the brain, a key neurotransmitter that facilitates communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2023. The medication has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.