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 drug, Spravato, as a standalone treatment for patients with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato is currently indicated for use alongside an oral antidepressant for individuals whose symptoms have not improved after trying two or more other antidepressants.
The company stated that nearly 30 percent of the approximately 280 million individuals worldwide diagnosed with major depressive disorder suffer from treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the struggles patients face when undergoing prolonged cycles of treatments that fail to alleviate their symptoms, which significantly impacts their quality of life.
The application to the FDA includes findings from a late-stage clinical trial indicating that Spravato can alleviate symptoms as soon as 24 hours post-treatment, and its effects can last for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a medical facility. Unlike traditional antidepressants that adjust the levels of neurotransmitters such as serotonin and dopamine, Spravato enhances levels of glutamate in the brain, which is the most prevalent neurotransmitter and essential for neuron communication.
Sales of Spravato increased 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 individuals across 77 countries, according to Johnson & Johnson.