Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) aimed at expanding the use of its ketamine-based medication, Spravato, to function as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside oral antidepressants for patients unresponsive to at least two different antidepressant medications. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles faced by patients dealing with difficult-to-treat depression, stating, “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 company’s application includes data from a late-stage clinical trial revealing that Spravato, when used as a standalone therapy, can alleviate patients’ symptoms as soon as 24 hours after the initial treatment and continue to provide relief for at least four weeks.
Spravato is administered via nasal spray and must be taken under a healthcare provider’s supervision in a clinical setting. Unlike traditional antidepressants that modify serotonin and dopamine levels, Spravato enhances glutamate activity in the brain. Glutamate, the brain’s most prevalent neurotransmitter, plays a crucial role in neuron communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same quarter in 2023. Johnson & Johnson reports that Spravato has been utilized by 100,000 patients across 77 countries.