Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato. The application aims for Spravato to be recognized as a standalone treatment for individuals dealing with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who did not see improvements after trying two or more antidepressants. Currently, approximately 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression, as noted by Johnson & Johnson.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the difficulties faced by patients with hard-to-treat depression, highlighting that many endure prolonged periods of ineffective treatments, adversely affecting their emotional and functional well-being.
The submission to the FDA includes findings from a late-stage clinical trial indicating that Spravato, when used alone, can alleviate symptoms within 24 hours of treatment, with effects lasting for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of healthcare professionals in a controlled setting. In contrast to traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances the levels of glutamate in the brain, which plays a crucial role in neuronal communication.
In terms of sales, Spravato witnessed a significant increase of 60%, reaching $271 million in revenue in the quarter ending June 30, compared to the same timeframe in 2023. The medication has been utilized by over 100,000 individuals across 77 countries, according to Johnson & Johnson.