Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, for treatment-resistant depression as a standalone therapy.
Spravato was first approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms did not respond to two or more previous antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the challenges faced by many patients struggling with difficult-to-treat depression, stating that they often endure prolonged periods trying multiple treatments that fail to alleviate their symptoms, which can impose a heavy emotional and functional toll on both patients and their families.
The application includes findings from a late-stage clinical trial indicating that Spravato, as a standalone treatment, can reduce patients’ symptoms as soon as 24 hours after administration and maintain this effect for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical environment. Unlike typical antidepressants that modify brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter that facilitates neuron communication.
Sales of Spravato experienced a significant increase of 60%, reaching $271 million for the three-month period ending June 30, compared to the same timeframe in 2023. The drug has been utilized by over 100,000 patients across 77 countries, according to Johnson & Johnson.