Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, to be used as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose depression symptoms did not improve after two or more treatments. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide who suffer from 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 supported by data from a late-stage clinical trial that demonstrated Spravato’s effectiveness as a standalone treatment, with patients noticing symptom relief as soon as 24 hours after administration and lasting for at least four weeks.
Spravato is delivered via a nasal spray and must be taken under the watchful eye of a healthcare provider. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is a key neurotransmitter facilitating communication between neurons.
Sales of Spravato experienced a significant increase, jumping 60% to $271 million in the three months ending June 30, compared to the same period in 2022. According to Johnson & Johnson, about 100,000 individuals across 77 countries have used Spravato.