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 be administered as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms have not improved after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “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 application was backed by data from a late-stage clinical trial indicating 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 delivered as a nasal spray and requires administration under the supervision of a healthcare professional in a clinical setting. Unlike conventional antidepressants that alter neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, aiding neuron communication as glutamate is the brain’s most prevalent neurotransmitter.
In terms of financial performance, sales of Spravato increased by 60% to $271 million for the three-month period ending June 30, compared to the same period in 2022. The medication has been utilized by approximately 100,000 patients across 77 countries, according to the company.