Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Spravato was first approved by the FDA in 2019, but only for use in conjunction with an oral antidepressant for patients who did not respond to two or more previous antidepressant treatments.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide affected by major depressive disorder suffer from 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 application includes data from a late-stage clinical trial indicating that Spravato, when administered alone, alleviated symptoms in patients as soon as 24 hours after the first treatment, with effects lasting for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that influence neurotransmitters like serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
In the second quarter of this year, Spravato’s sales surged by 60% to reach $271 million compared to the same period in 2023. The medication has been utilized by 100,000 people across 77 countries, according to Johnson & Johnson.