Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, for treatment-resistant depression as a standalone therapy.
Initially approved by the FDA in 2019, Spravato was indicated for use in conjunction with an oral antidepressant for patients who had not found relief from two or more antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the 280 million individuals worldwide diagnosed with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated that many patients with difficult-to-treat depression often undergo prolonged cycles of ineffective treatments, leading to substantial emotional and functional challenges for themselves and their families.
The company’s application was supported by data from a late-stage clinical trial, which demonstrated that Spravato, when administered as a standalone treatment, could alleviate symptoms as quickly as 24 hours after administration and sustain relief for a minimum of four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare professional. Unlike traditional antidepressants that primarily target serotonin and dopamine levels, Spravato enhances glutamate in the brain, which is the most prevalent neurotransmitter facilitating communication between neurons.
Sales of Spravato have seen remarkable growth, surging 60% to $271 million in the second quarter of 2023 compared to the same period last year. The drug has been utilized by approximately 100,000 patients across 77 countries, according to Johnson & Johnson.