Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based drug, Spravato, as a standalone therapy for treatment-resistant depression.
Initially approved in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson highlighted that nearly 30% of the 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression, noting that many endure prolonged cycles of ineffective treatments, which can impose a significant emotional and functional burden on both patients and their families.
The submission to the FDA was accompanied by data from a late-stage clinical trial, which indicated that Spravato effectively alleviated patients’ symptoms within 24 hours of treatment and sustained relief for at least four weeks.
Administered as a nasal spray, Spravato must be taken under the supervision of a healthcare professional in designated settings. Unlike traditional antidepressants that target chemicals such as serotonin and dopamine, Spravato functions by increasing glutamate levels in the brain, facilitating communication between neurons.
Sales of Spravato experienced a remarkable 60% increase, reaching $271 million in the quarter ending June 30 compared to the same period in 2023. The drug has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.