Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking approval to expand the use of its ketamine-based drug, Spravato, as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients whose symptoms persisted despite undergoing treatment with two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, Head of Neuroscience at Johnson & Johnson, stated, “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 request was supported by data from a late-stage clinical trial, indicating that Spravato, when used alone, alleviated patient symptoms as soon as 24 hours after treatment and continued to show effects for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that typically influence neurotransmitters such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is crucial for neuron communication.
Sales of Spravato rose by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reports that the medication has been utilized by 100,000 individuals across 77 countries.