Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to extend the use of its ketamine-based drug, Spravato, as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was intended for use in combination with an oral antidepressant for patients whose symptoms did not improve with at least two other antidepressants.
Nearly 30 percent of the estimated 280 million people globally living with major depressive disorder have treatment-resistant depression, according to Johnson & Johnson.
“Many patients enduring difficult-to-treat depression experience prolonged periods cycling through multiple treatments that fail to effectively alleviate their symptoms, contributing to considerable functional and emotional strain on both patients and their loved ones,” said Bill Martin, Johnson & Johnson’s head of neuroscience, in a press release.
The submitted application includes data from a late-stage clinical trial in which Spravato, used as a standalone treatment, was shown to alleviate patients’ symptoms as early as 24 hours after treatment, with effects lasting at least four weeks.
Spravato is administered as a nasal spray under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that regulate chemicals such as serotonin and dopamine in the brain, Spravato works by increasing levels of glutamate, the brain’s most abundant neurotransmitter, which facilitates communication between neurons.
Sales of Spravato surged 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. The drug has been used by 100,000 people in 77 countries, as reported by Johnson & Johnson.