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 therapy for treatment-resistant depression.
Originally approved in 2019, the FDA had permitted Spravato to be used in conjunction with an oral antidepressant for patients whose symptoms failed to improve despite undergoing treatment with two or more antidepressants.
According to Johnson & Johnson, approximately 30 percent of the estimated 280 million individuals globally 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 application to the FDA is backed by data from a late-stage clinical trial, which revealed that Spravato, when administered as a standalone treatment, alleviated patients’ symptoms within as little as 24 hours and continued to be effective for at least four weeks.
Spravato is delivered through a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike other antidepressants that typically regulate brain chemicals such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain. Glutamate is the most abundant neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged by 60% to $271 million during the three months ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the medication has been utilized by 100,000 individuals in 77 countries.