Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based drug, Spravato. The company aims for it to be utilized as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients who did not see improvement after trying two or more antidepressants. According to Johnson & Johnson, approximately 30 percent of the 280 million individuals worldwide suffering from major depressive disorder are affected by treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the challenges faced by many patients struggling with difficult-to-treat depression. He noted that these patients often try multiple treatments that fail to resolve their symptoms, leading to significant emotional and functional distress for themselves and their families.
The submission to the FDA was supported by data from a late-stage clinical trial, which demonstrated that Spravato, when used as a standalone treatment, alleviated symptoms in patients as quickly as 24 hours after administration and remained effective for at least four weeks.
Spravato is administered through a nasal spray and requires supervision from a healthcare provider during use. Unlike typical antidepressants that target chemicals like serotonin and dopamine, Spravato enhances the levels of glutamate in the brain, a neurotransmitter that facilitates communication between neurons.
Sales of Spravato have surged, with a 60% increase to $271 million in the quarter ending June 30 compared to the same quarter in 2023. The drug has been utilized by 100,000 people across 77 countries, according to the company’s report.