Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, allowing it to be prescribed as a standalone treatment for individuals suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use in conjunction with an oral antidepressant for patients whose depression did not improve after trying two or more different medications.
According to Johnson & Johnson, nearly 30 percent of the 280 million people worldwide diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, expressed the challenges faced by patients with difficult-to-treat depression. He 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 for expanded use was supported by data from a late-stage clinical trial which demonstrated that Spravato can alleviate symptoms in patients as early as 24 hours after administration and maintain those effects 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. Different from traditional antidepressants that target chemicals like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, a neurotransmitter critical for neuronal communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30 compared to the same period in 2023. Johnson & Johnson reported that the drug has been utilized by 100,000 patients in 77 countries.