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, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use in conjunction with an oral antidepressant, aimed at patients whose symptoms failed to improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide living with major depressive disorder are affected by treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted in a press release that “many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The request was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, could alleviate patients’ symptoms as quickly as 24 hours after administration and maintain efficacy for at least four weeks.
Spravato is delivered as a nasal spray and requires administration under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that modulate chemicals like serotonin and dopamine in the brain, Spravato works by enhancing glutamate levels, the most prevalent neurotransmitter in the brain that facilitates neuron communication.
Sales of Spravato increased by 60%, reaching $271 million during the three months ending June 30, compared to the same period in 2023. The drug has been used by approximately 100,000 people across 77 countries, according to Johnson & Johnson.