Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to extend the use of its ketamine-based drug, Spravato, for treatment-resistant depression as a standalone therapy.
Spravato was first approved by the FDA in 2019, but only in combination with an oral antidepressant for patients who did not respond to two or more other antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 for standalone use was supported by data from a late-stage clinical trial, indicating that Spravato alleviated symptoms for patients as soon as 24 hours after treatment and lasted for at least four weeks.
Spravato is administered via a nasal spray and must be taken under the supervision of a healthcare professional in a proper healthcare setting. Unlike traditional antidepressants that typically target brain chemicals like serotonin and dopamine, Spravato functions by increasing glutamate levels, the most prevalent neurotransmitter that facilitates neuron communication in the brain.
Sales of Spravato have risen significantly, recording a 60% increase to $271 million in the quarter ending June 30, compared to the same time in 2023. According to the company, Spravato has been used by around 100,000 patients across 77 countries.