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 medication, Spravato, allowing it to be utilized 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 didn’t improve after trying two or more antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the 280 million individuals worldwide living with major depressive disorder struggle with treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression, stating that they often endure prolonged periods trying multiple ineffective treatments, resulting in significant emotional and functional burdens for both patients and their families.
The submission to the FDA included findings from a late-stage clinical trial that indicated Spravato, when used alone, began to alleviate symptoms in patients as quickly as 24 hours after treatment and maintained efficacy for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider. Unlike traditional antidepressants, which focus on regulating brain chemicals such as serotonin and dopamine, Spravato enhances glutamate, the brain’s most prevalent neurotransmitter, facilitating neuron communication.
In recent financial results, sales of Spravato surged by 60% to $271 million for the quarter ending June 30, compared to the same quarter in 2023. The medication has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.