Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approval of its ketamine-based medication, Spravato, for use as a standalone treatment for individuals suffering from treatment-resistant depression.
The FDA first granted approval for Spravato in 2019, allowing its use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide who have major depressive disorder experience treatment-resistant depression.
“Patients dealing with hard-to-treat depression often go through prolonged cycles of various treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for both themselves and their loved ones,” stated Bill Martin, Head of Neuroscience at Johnson & Johnson, in a press release.
The submission to the FDA included data from a late-stage clinical trial, which indicated that Spravato effectively reduced symptoms as quickly as 24 hours after treatment and maintained improvement 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 clinical setting. Unlike traditional antidepressants that alter serotonin and dopamine levels in the brain, Spravato enhances glutamate activity. Glutamate is the most prevalent neurotransmitter in the brain and plays a crucial role in neuronal communication.
Sales for Spravato rose by 60% to reach $271 million in the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by around 100,000 patients in 77 countries, according to Johnson & Johnson.