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 intended to be used in conjunction with an oral antidepressant for patients who had not seen improvements after trying two or more antidepressants. Johnson & Johnson highlighted that nearly 30% of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, 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 submitted to the FDA includes data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as quickly as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate, recognized as the brain’s most abundant neurotransmitter, plays a crucial role in neuronal communication.
Sales of Spravato surged by 60% to $271 million during the three months ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.