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 with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 as part of a combination therapy with an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressant medications. Johnson & Johnson noted that nearly 30% of the approximately 280 million individuals 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 included data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone therapy, provided symptom relief to patients as quickly as 24 hours after administration and maintained effectiveness 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 affect neurotransmitters like serotonin and dopamine, Spravato enhances the function of glutamate, the most abundant neurotransmitter in the brain, facilitating communication between neurons.
The sales of Spravato saw a remarkable increase of 60%, reaching $271 million in the quarter ending June 30, in comparison to the same period in 2023. Johnson & Johnson reported that Spravato has been used by 100,000 individuals across 77 countries.