Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to extend the approved use of its ketamine-based medication, Spravato, allowing it to be used as a standalone therapy for patients 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, around 30 percent of the approximately 280 million individuals globally diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the need for effective treatments, stating that many patients endure prolonged periods of trying various therapies that fail to alleviate their symptoms, leading to significant emotional and functional distress for both patients and their families.
The new application to the FDA is backed by data from a late-stage clinical trial, which revealed that Spravato, when used as a standalone treatment, began to alleviate symptoms within 24 hours and provided relief for at least four weeks.
Spravato is administered as a nasal spray and must be used under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that affect brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is crucial for neuronal communication.
In recent financial results, Johnson & Johnson reported that sales of Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 patients across 77 countries.