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 utilized as a standalone treatment for patients suffering from treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30% of the 280 million individuals globally living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the challenges faced by patients with difficult-to-treat depression, noting that they often endure lengthy periods attempting multiple treatments that fail to alleviate their symptoms, which can create a significant emotional and functional burden for both patients and their families.
The recent application includes findings from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, could alleviate patient symptoms as quickly as 24 hours after administration and continued to do so for at least four weeks.
Administered as a nasal spray, Spravato must be taken under the supervision of a healthcare provider in a clinical setting. In contrast to other antidepressants that primarily affect brain chemicals like serotonin and dopamine, Spravato functions by enhancing levels of glutamate, the brain’s most prevalent neurotransmitter, which is essential for neuron communication.
Sales of Spravato saw a 60% increase, reaching $271 million during the three months ending on June 30, compared to the same period in 2022. According to Johnson & Johnson, the drug has been used by 100,000 patients across 77 countries.