Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug Spravato as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressant medications.
Johnson & Johnson noted that nearly 30 percent of the estimated 280 million people worldwide suffering from 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 create a significant functional and emotional burden on patients and their loved ones.”
The application was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, significantly alleviated symptoms in patients within 24 hours and maintained these effects for at least four weeks.
Spravato is administered via a nasal spray and must be taken in a healthcare setting under the supervision of a healthcare professional. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato functions by increasing glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and plays a crucial role in neuron communication.
Sales of Spravato experienced a remarkable 60% increase, reaching $271 million in the three months ending June 30, compared to the same period in 2023. According to Johnson & Johnson, the medication has been utilized by 100,000 individuals across 77 countries.