Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be used as a standalone treatment for patients with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was aimed at patients who had not responded to two or more antidepressants and was intended to be used alongside an oral antidepressant.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles faced by patients with difficult-to-treat depression, noting that they often go through numerous ineffective treatments, leading to significant emotional and functional challenges for both patients and their families.
The application to the FDA is supported by data from a late-stage clinical trial demonstrating that Spravato, when used alone, provided relief from symptoms as quickly as 24 hours after administration and maintained this effect for at least four weeks.
Spravato is given as a nasal spray and must be administered under the supervision of a healthcare professional. Unlike traditional antidepressants that typically target serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuron communication.
Sales of Spravato surged by 60%, reaching $271 million during the three months ending June 30, compared to the same period in 2023. The drug has been utilized by around 100,000 patients across 77 countries, as reported by Johnson & Johnson.