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, allowing it to be utilized as a standalone treatment for individuals suffering from treatment-resistant depression.
Initially authorized by the FDA in 2019, Spravato was approved for use in conjunction with an oral antidepressant for patients whose depression did not respond to two or more other antidepressant treatments.
According to Johnson & Johnson, approximately 30 percent of the estimated 280 million individuals globally diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, commented 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 to the FDA is supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone therapy, can alleviate symptoms as soon as 24 hours after treatment and maintain those effects for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that primarily regulate neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter in the brain, playing a crucial role in neuronal communication.
Sales of Spravato increased by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. According to Johnson & Johnson, the medication has been utilized by 100,000 patients in 77 countries.