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, to serve as a standalone treatment for patients with treatment-resistant depression.
Spravato initially received FDA approval in 2019 for use in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants. The company reports that nearly 30 percent 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, stating that many spend too much time trying various treatments that do not alleviate their symptoms, leading to significant emotional and functional burdens.
The application was supported by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, began to relieve symptoms within 24 hours and provided relief for at least four weeks.
Administered as a nasal spray, Spravato must be used under the supervision of a healthcare provider in a clinical setting. Unlike other antidepressants that focus on the regulation of neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and essential for neuron communication.
Sales of Spravato increased by 60% to $271 million for the three months ending June 30, compared to the same period in 2023. Johnson & Johnson reports that the drug has been utilized by 100,000 individuals across 77 countries.