Johnson & Johnson announced on Monday that it has applied to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, to function as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 as an adjunct treatment, to be used alongside an oral antidepressant for patients who did not respond to two or more antidepressants.
The company highlighted that nearly 30 percent of the approximately 280 million individuals worldwide with major depressive disorder suffer from treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the challenges faced by patients who often undergo a lengthy process with ineffective treatments that can lead to significant emotional and functional distress for them and their families.
The application for expanded use was supported by data from a late-stage clinical trial indicating that Spravato, when used alone, was effective in alleviating symptoms as soon as 24 hours after treatment and continued to offer relief for at least four weeks.
Spravato is administered as a nasal spray and must be taken in the presence of a healthcare professional. Unlike typical antidepressants that target chemicals like serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato experienced a notable increase of 60%, reaching $271 million in the three months ending June 30, compared to the same timeframe in 2023. The drug has been utilized by around 100,000 individuals across 77 countries, as reported by Johnson & Johnson.