Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) aimed at broadening the approved use of its ketamine-based medication, Spravato, to function as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in cases where patients did not respond to at least two other antidepressant drugs.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people globally affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients dealing with hard-to-treat depression endure prolonged periods trying multiple treatments that fail to alleviate their symptoms, creating a substantial functional and emotional burden for them and their families.”
The application to the FDA includes findings from a late-stage clinical trial demonstrating that Spravato, as an independent treatment, provided symptom relief for patients within 24 hours and maintained effectiveness for at least four weeks.
Spravato is administered as a nasal spray under the supervision of a healthcare professional in a clinical setting. Unlike conventional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances the activity of glutamate in the brain, which is the most prevalent neurotransmitter and crucial for neuronal communication.
Sales of Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same period in 2022. The drug has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.