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. The new application aims for Spravato to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Spravato originally received FDA approval in 2019 but was initially designated for use alongside an oral antidepressant for patients who did not find relief after trying two or more traditional antidepressants. Johnson & Johnson highlighted that around 30% of the 280 million individuals globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the struggles faced by patients dealing with difficult-to-treat depression, noting the considerable emotional and functional toll it can take on both patients and their families. This new application is backed by findings from a late-stage clinical trial, which demonstrated that Spravato, when used as a standalone therapy, provided symptom relief for patients as quickly as 24 hours after the initial treatment, with sustained benefits lasting at least four weeks.
Spravato is administered through a nasal spray and is required to be taken under the supervision of a healthcare professional in a clinical setting. Unlike conventional antidepressants, which target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, facilitating neuronal communication.
In terms of market performance, sales of Spravato have surged by 60% to $271 million in the second quarter of 2023 compared to the same period last year. The medication has already been implemented by approximately 100,000 patients across 77 countries, reflecting its growing acceptance in the global healthcare landscape.
This development signals a step forward in addressing a significant gap in the treatment of depression, offering hope for patients who have struggled to find effective relief from their symptoms.
In summary, Johnson & Johnson’s initiative to expand Spravato’s indications could mark a breakthrough for many patients battling treatment-resistant depression, paving the way for quicker and potentially more effective interventions.