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 medication, Spravato, to function as a standalone therapy for treatment-resistant depression.
The FDA first granted approval for Spravato in 2019, allowing it to be used in combination with an oral antidepressant for patients who had not seen improvement after trying two or more antidepressants.
Approximately 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder are affected by treatment-resistant depression, according to Johnson & Johnson.
“Numerous patients dealing with difficult-to-treat depression endure prolonged periods cycling through various treatments that fail to alleviate their symptoms, resulting in considerable emotional and functional strain on both themselves and their families,” detailed Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application includes results from a late-stage clinical trial that indicated Spravato, as a solo treatment, alleviated patients’ symptoms as soon as 24 hours after administration and maintained efficacy for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical environment. Unlike conventional antidepressants that modify brain chemicals like serotonin and dopamine, Spravato enhances glutamate activity in the brain. Glutamate, being the most prevalent neurotransmitter, plays a crucial role in neuronal communication.
Sales of Spravato surged 60% to $271 million in the quarter ending June 30, compared to the same period in 2020. Johnson & Johnson reports that Spravato has been utilized by 100,000 patients across 77 countries.