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, to function as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30% of the approximately 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the challenges faced by patients dealing with difficult-to-treat depression, stating that many spend excessive time cycling through various treatments that fail to alleviate their symptoms, leading to significant emotional and functional burdens on both the patients and their families.
The application submitted to the FDA includes data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, can begin to relieve patients’ symptoms within 24 hours and maintains its effectiveness for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target chemicals like serotonin and dopamine in the brain, Spravato operates by enhancing glutamate levels. Glutamate is the most prevalent neurotransmitter in the brain, playing a crucial role in neuron communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2022. Johnson & Johnson stated that the drug has been utilized by 100,000 individuals across 77 countries.