Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the approval of its ketamine-based drug, Spravato, to be used as a standalone therapy for treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use in conjunction with an oral antidepressant for patients who saw no improvement after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals globally with 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 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.
Administered as a nasal spray, Spravato must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that focus on regulating brain chemicals such as serotonin and dopamine, Spravato enhances glutamate activity, the most prevalent neurotransmitter in the brain that facilitates neuron communication.
Sales of Spravato surged by 60% to $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 Johnson & Johnson.