Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be utilized 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 symptoms did not improve after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals globally affected by 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 application was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, began alleviating symptoms within 24 hours for some patients and remained effective for at least four weeks.
Spravato is administered as a nasal spray under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that influence neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, facilitating neuron communication.
Sales of Spravato saw a significant increase of 60%, reaching $271 million in the three months ending June 30, compared to the same quarter in 2022. The medication has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.