Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, for treatment-resistant depression as a standalone therapy.
Spravato was first approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms inadequately responded to two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide living with major depressive disorder have 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 submission of the application included data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated patient symptoms as soon as 24 hours post-treatment and continued to do so for at least four weeks.
Spravato is administered via a nasal spray and is required to be taken under the supervision of a healthcare provider in a medical facility. Unlike traditional antidepressants, which primarily target neurotransmitters such as serotonin and dopamine, Spravato functions by enhancing glutamate, the most prevalent neurotransmitter in the brain, facilitating communication between neurons.
In addition, sales of Spravato increased by 60%, reaching $271 million in the three months ending June 30, compared to the same period in 2023. To date, Spravato has been utilized by approximately 100,000 patients across 77 countries, as reported by Johnson & Johnson.