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, so that it can be administered as a standalone therapy for patients suffering from treatment-resistant depression.
Spravato received FDA approval in 2019 for use alongside an oral antidepressant for individuals whose conditions did not improve despite trying two or more antidepressants. According to Johnson & Johnson, almost 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated 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 company’s application was accompanied by results from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, was effective in alleviating patients’ symptoms as soon as 24 hours after administration and continued to do so for at least four weeks.
Administered as a nasal spray, Spravato must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that primarily affect neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate activity in the brain. Glutamate is the brain’s most prevalent neurotransmitter and plays a key role in neuronal communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30 compared to the same period in 2023. The treatment has been utilized by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.