Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based medication, Spravato, to function as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside oral antidepressants for patients whose symptoms did not improve after trying two or more antidepressant medications. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the plight of patients facing difficult-to-treat depression, stating that many often go through numerous ineffective treatments that can heavily impact their emotional and functional well-being.
The application submitted to the FDA included results from a late-stage clinical trial demonstrating that Spravato, when used independently, alleviated patients’ symptoms within 24 hours and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of healthcare professionals in a clinical environment. Unlike traditional antidepressants that typically adjust brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels, the most prevalent neurotransmitter, facilitating communication between neurons.
Sales for Spravato surged by 60% to $271 million during the quarter ending June 30, compared to the same period in the previous year. Johnson & Johnson reported that the treatment has been utilized by 100,000 individuals across 77 countries.