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, as a standalone therapy for patients with treatment-resistant depression.
Initially approved in 2019, Spravato was designed to be used alongside an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide affected by major depressive disorder struggle with treatment-resistant depression.
Bill Martin, the 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 for expanded use is supported by data from a late-stage clinical trial that indicated Spravato could alleviate symptoms as quickly as 24 hours after administration and maintain efficacy for at least four weeks.
Administered as a nasal spray, Spravato must be taken under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most abundant neurotransmitter and crucial for neuronal communication.
Sales of Spravato experienced a significant increase of 60%, reaching $271 million in the second quarter of 2023 compared to the same period last year. The medication has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.