Johnson & Johnson announced on Monday that it has submitted a new application to the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-based drug, Spravato, allowing it to be used as a standalone treatment for treatment-resistant depression.
The FDA initially approved Spravato in 2019 as an adjunct therapy to be administered alongside an oral antidepressant for patients whose depression did not improve after trying two or more other 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, the 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, which can cause a significant functional and emotional burden on patients and their loved ones.”
The application for expanded use was supported by findings from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, was effective in alleviating symptoms in patients as quickly as 24 hours after administration, and this effect persisted for at least four weeks.
Administered as a nasal spray, Spravato must be used under the supervision of a healthcare provider within a clinical setting. Unlike traditional antidepressants that primarily affect serotonin and dopamine levels in the brain, Spravato enhances glutamate activity. Glutamate is the brain’s most prevalent neurotransmitter and is crucial for neuronal communication.
Spravato’s sales surged by 60% to $271 million in the three months ending June 30, compared to the same period in 2023. To date, approximately 100,000 people in 77 countries have utilized Spravato, according to Johnson & Johnson.