Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the indications for its ketamine-based medication, Spravato, allowing it to be used as an independent treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for individuals whose symptoms did not alleviate after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30% of the 280 million individuals worldwide diagnosed with 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 company’s application included findings from a late-stage clinical trial indicating that Spravato, when used alone, showed a reduction in symptoms within 24 hours after treatment and continued to provide relief for up to four weeks.
Spravato is administered as a nasal spray and is required to be taken under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that primarily affect neurotransmitters like serotonin and dopamine, Spravato enhances glutamate activity in the brain. Glutamate is the most prevalent neurotransmitter in the brain and is essential for neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million for the quarter ending June 30, compared to the same period last year. The medication has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.