Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, for standalone treatment of treatment-resistant depression.
Spravato received FDA approval in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms have not improved despite trying two or more different antidepressants.
Johnson & Johnson noted that nearly 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder suffer from treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression endure prolonged cycles of ineffective treatments that fail to alleviate their symptoms, leading to significant emotional and functional burdens on both patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application includes data from a late-stage clinical trial indicating that Spravato, when used alone, can significantly reduce patients’ symptoms as quickly as 24 hours after administration and remain effective for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that modify brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuron communication.
In the three-month period ending June 30, sales of Spravato surged by 60% to $271 million compared to the same quarter in 2023. Johnson & Johnson reported that the medication has been prescribed to 100,000 individuals across 77 countries.