Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone treatment for those suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 as a treatment that could be used alongside an oral antidepressant for patients who had not found relief after trying two or more other antidepressants. The company noted that nearly 30 percent of the approximately 280 million people worldwide with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the difficulties faced by patients dealing with hard-to-treat depression. He stated that many of them endure prolonged periods trying various ineffective treatments, which can lead to significant emotional and functional burdens on them and their families.
The application to the FDA was backed by data from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, could alleviate patient symptoms within 24 hours and maintain that relief for at least four weeks.
Spravato is administered as a nasal spray and must be taken in a healthcare setting under the supervision of a medical professional. Unlike traditional antidepressants that typically work by regulating brain chemicals like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a key role in neuron communication.
Sales of Spravato surged by 60% to $271 million in the second quarter of this year, compared to the same timeframe in 2023. According to Johnson & Johnson, Spravato has been utilized by 100,000 individuals across 77 countries.