Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone treatment for those suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 to be used alongside an oral antidepressant for patients who did not see improvement after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30% of the approximately 280 million individuals globally grappling with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The application was accompanied by data from a late-stage clinical trial revealing that Spravato, when used as a standalone treatment, was effective in alleviating symptoms as soon as 24 hours post-treatment and maintained efficacy for at least four weeks.
Administered as a nasal spray, Spravato must be taken under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that modify brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and crucial for neuronal communication.
Sales of Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same timeframe in 2023. The drug has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.