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, for use as a standalone therapy in treating resistant depression.
Spravato was initially approved by the FDA in 2019, but only to be used in conjunction with an oral antidepressant for patients whose symptoms failed to improve after trying two or more antidepressants. Johnson & Johnson noted that nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder experience treatment-resistant depression.
In a press release, Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression. He mentioned that many of these individuals endure prolonged periods cycling through various treatments that do not resolve their symptoms, leading to significant emotional and functional burdens on both patients and their families.
The application to the FDA was supported by data from a late-stage clinical trial indicating that Spravato, when used alone, was effective in alleviating patients’ symptoms as quickly as 24 hours after treatment and maintained this improvement for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most abundant neurotransmitter and plays a crucial role in neuron communication.
Sales of Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same period in 2022. According to Johnson & Johnson, the drug has been utilized by 100,000 patients across 77 countries.