Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) for the approval to use its ketamine-based medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants. According to Johnson & Johnson, nearly 30% of the estimated 280 million people globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated that many patients dealing with difficult-to-treat depression often go through numerous treatments that fail to alleviate their symptoms, leading to significant emotional and functional burdens on both patients and their families.
The company’s application includes data from a late-stage clinical trial that demonstrated Spravato, when used alone, began to alleviate patients’ symptoms within 24 hours of treatment and had a lasting effect 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 medical facility. Unlike standard antidepressants that typically target brain chemicals like serotonin and dopamine, Spravato functions by increasing the level of glutamate, the brain’s most prevalent neurotransmitter, enhancing neuronal communication.
Sales of Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same timeframe in 2022. The medication has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.