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, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was only allowed to be used in conjunction with an oral antidepressant for individuals who did not see improvements after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that “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 lead to significant functional and emotional burdens on patients and their families.”
The submission to the FDA included data from a late-stage clinical trial, indicating that Spravato as a standalone treatment could alleviate patients’ symptoms as quickly as 24 hours after administration and maintain effectiveness for at least four weeks.
Spravato is administered via nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that influence neurotransmitters like serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and essential for neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million for the three-month period ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.