Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the usage of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato received initial FDA approval in 2019, allowing its use in conjunction with an oral antidepressant for patients who did not experience improvements after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million individuals globally affected by major depressive disorder grapple with treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the struggles faced by patients dealing with hard-to-treat depression, noting that they often experience prolonged periods of ineffective treatment, which can lead to significant emotional and functional challenges for both the patients and their families.
The application for expanded use was supported by data from a late-stage clinical trial, which indicated that Spravato as a standalone treatment began alleviating symptoms as soon as 24 hours post-treatment, with effects lasting for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target brain chemicals like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain. Glutamate, the most prevalent neurotransmitter, plays a key role in neuronal communication.
In addition, sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in the previous year. Johnson & Johnson reports that Spravato has been prescribed to 100,000 patients across 77 countries.