Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to extend the approved use of its ketamine-based medication, Spravato, as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for patients who had not seen improvement after two or more antidepressant treatments.
The company noted that nearly 30 percent of the 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Patients grappling with difficult-to-treat depression often endure prolonged periods trying multiple ineffective treatments, which can lead to significant emotional and functional strains for themselves and their families,” said Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application includes data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone therapy, alleviated patients’ symptoms as quickly as 24 hours after administration and maintained effects for at least four weeks.
Spravato is delivered through a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants, which generally affect neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, facilitating neuron communication.
Sales for Spravato surged by 60%, reaching $271 million in the three-month period ending June 30, compared to the same timeframe in 2022. The medication has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.