Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
The FDA originally approved Spravato in 2019, but its use was restricted to being combined with an oral antidepressant for patients who did not see improvement after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide affected by major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 for expanded use is supported by findings from a late-stage clinical trial, which indicated that Spravato provided relief from symptoms as soon as 24 hours post-treatment and maintained efficacy for at least four weeks.
Spravato is administered as a nasal spray and must be taken in a healthcare setting under professional supervision. Unlike traditional antidepressants, which target the brain’s serotonin and dopamine levels, Spravato enhances glutamate levels, the brain’s most prevalent neurotransmitter that facilitates neuron communication.
Sales of Spravato surged by 60% to $271 million in Q2 compared to the same period in 2023. The medication has been utilized by around 100,000 patients across 77 countries, as reported by Johnson & Johnson.