Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, to function as a standalone treatment for patients with treatment-resistant depression.
The FDA initially approved Spravato in 2019, allowing its use in combination with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressant medications.
According to Johnson & Johnson, nearly 30% of the estimated 280 million people worldwide diagnosed with major depressive disorder struggle with treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized in a press release that “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 that demonstrated Spravato, when used alone, alleviated patient symptoms as quickly as 24 hours after treatment and sustained relief for at least four weeks.
Spravato is provided as a nasal spray and must be administered under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that target serotonin and dopamine levels in the brain, Spravato enhances glutamate activity. Glutamate, the most prevalent neurotransmitter in the brain, plays a crucial role in neuronal communication.
Sales for Spravato surged by 60%, reaching $271 million during the three months ending June 30, compared to the same period the previous year. Johnson & Johnson reported that Spravato has been utilized by 100,000 people across 77 countries.