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 individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was previously indicated for use in conjunction with an oral antidepressant for patients who did not respond to two or more conventional antidepressants.
The company revealed that nearly 30 percent of the approximately 280 million people globally diagnosed with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the challenges faced by patients battling hard-to-treat depression, stating that many endure prolonged periods trying various treatments that fail to alleviate their symptoms, resulting in significant emotional and functional distress for both them and their families.
The application to the FDA was supported by results from a late-stage clinical trial, indicating that Spravato, when used as a standalone treatment, provided relief to patients as quickly as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and is required to be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that primarily act on serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and facilitates neuronal communication.
In the last three months ending June 30, sales of Spravato surged by 60% to $271 million compared to the same period in 2023, with the treatment being utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.