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. The application seeks to classify Spravato as a standalone therapy for treating individuals with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was permitted for use only in conjunction with an oral antidepressant for patients who did not respond to two or more standard antidepressants. Johnson & Johnson stated that nearly 30 percent of the 280 million people globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggle faced by patients with difficult-to-treat depression, stating that many endure lengthy cycles of ineffective treatments, leading to significant emotional and functional challenges for both patients and their families.
The application is supported by data from a late-stage clinical trial, indicating that Spravato as a standalone treatment alleviated patient symptoms as early as 24 hours after administration and sustained relief for at least four weeks. Spravato is delivered as a nasal spray and requires administration under the supervision of a healthcare provider. Unlike traditional antidepressants that target brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels, the brain’s most prevalent neurotransmitter, facilitating neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million for the quarter ending June 30, compared to the same period last year. The drug has been utilized by approximately 100,000 patients across 77 countries, according to the company.