Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant specifically for patients whose symptoms did not improve despite trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder contend with treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggle many patients face, stating, “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 company’s recent application is supported by data from a late-stage clinical trial that indicated Spravato, when used as an independent treatment, alleviated patients’ symptoms in as little as 24 hours and continued to be effective for at least four weeks.
Administered as a nasal spray, Spravato must be taken under medical supervision in a healthcare environment. Unlike typical antidepressants that focus on regulating brain chemicals like serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain. Glutamate is the predominant neurotransmitter and plays a crucial role in neuronal communication.
Sales for Spravato surged by 60% to reach $271 million in the three-month period ending June 30, compared to the same timeframe in 2023. The drug has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.