Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to extend the approval of its ketamine-based drug Spravato for use as a standalone treatment for treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for patients whose symptoms had not improved despite trying two or more oral antidepressants. The company noted that nearly 30 percent of the estimated 280 million individuals globally who suffer 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, which can cause a significant functional and emotional burden on patients and their loved ones.”
The application for expanded use is supported by data from a late-stage clinical trial that demonstrated Spravato’s effectiveness as a standalone therapy, showing symptom relief as early as 24 hours after treatment and lasting for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider. Unlike traditional antidepressants that target serotonin and dopamine levels in the brain, Spravato functions by enhancing levels of glutamate, the most prevalent neurotransmitter which aids neuron communication.
In the second quarter of 2023, sales of Spravato surged 60% to $271 million compared to the same timeframe the previous year. To date, Spravato has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.