Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in combination with an oral antidepressant for patients whose conditions did not improve despite trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder experience treatment-resistant depression.
“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,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application to the FDA is supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as soon as 24 hours after administration and sustained relief for at least four weeks.
Spravato is delivered via a nasal spray and must be administered under the supervision of a healthcare provider in a medical setting. Unlike conventional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato increases levels of glutamate, the most prevalent neurotransmitter in the brain, facilitating neuron communication.
Sales for Spravato surged 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The drug has been utilized by 100,000 individuals across 77 countries, according to the company.