Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to extend the approved use of its ketamine-based medication, Spravato, to function as a standalone treatment for individuals with treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant in patients whose symptoms showed no improvement after two or more antidepressant treatments.
Johnson & Johnson highlighted that approximately 30 percent of the 280 million people globally diagnosed with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients with hard-to-treat depression spend far too long going through various treatments that fail to alleviate their symptoms, leading to significant functional and emotional burdens for both them and their families.”
The application to the FDA includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can alleviate patients’ symptoms as quickly as 24 hours after administration and continues to do so for at least four weeks.
Spravato is dispensed as a nasal spray and must be administered in a healthcare setting with supervision from a medical provider. Unlike traditional antidepressants that impact neurotransmitters such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and is essential for neuronal communication.
Sales of Spravato experienced a remarkable 60% increase, reaching $271 million in the quarter that ended June 30, compared to the same period in the previous year. According to Johnson & Johnson, Spravato has been utilized by 100,000 individuals across 77 countries.