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, as a standalone treatment for resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant for patients whose symptoms did not respond to two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, resulting in significant emotional and functional burdens on both patients and their families.”
The application was supported by data from a late-stage clinical study indicating that Spravato, when used alone, improved patients’ symptoms within 24 hours and maintained that relief for at least four weeks.
Administered as a nasal spray under the supervision of a healthcare provider, Spravato differentiates itself from other antidepressants by enhancing glutamate levels in the brain, rather than regulating serotonin or dopamine. Glutamate, the most prevalent neurotransmitter, facilitates communication between neurons.
Sales for Spravato surged by 60%, reaching $271 million in the second quarter compared to the same period in the previous year. To date, Spravato has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.