Johnson & Johnson announced on Monday that it has filed a request with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, noted in a press release that many patients endure lengthy periods of trying multiple ineffective treatments, which can lead to significant emotional and functional burdens on both them and their families.
The application submitted includes data from a late-stage clinical trial, indicating that Spravato as a standalone treatment was effective in alleviating patients’ symptoms as early as 24 hours post-treatment and sustained relief for at least four weeks.
Spravato is administered via nasal spray and must be used under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the brain’s most abundant neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato experienced a remarkable 60% increase, reaching $271 million for the three-month period ending June 30, compared to the same timeframe in 2023. The medication has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.