Johnson & Johnson has announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) aimed at expanding the use of its ketamine-based drug, Spravato. The new application seeks to allow Spravato to be used as a standalone treatment for individuals suffering from treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was initially indicated for use in conjunction with an oral antidepressant for patients who had not seen improvements from two or more prior antidepressant therapies. Johnson & Johnson’s statistics suggest that nearly 30% of the approximately 280 million people globally living with major depressive disorder grapple with treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, highlighted the difficulties many patients face, often enduring prolonged periods trying various treatments that do not alleviate their symptoms. He emphasized the significant emotional and functional toll that such challenges can inflict on both patients and their families.
The recent application includes data from a late-stage clinical trial, which indicated that Spravato, when used alone, showed effectiveness in reducing symptoms of depression as soon as 24 hours after administration and continued to do so for at least four weeks thereafter. Spravato is administered as a nasal spray and is necessary to be taken under the supervision of a healthcare provider within a treatment facility. Unlike conventional antidepressants that primarily target serotonin and dopamine levels, Spravato operates by enhancing the function of glutamate, the brain’s most prevalent neurotransmitter, which plays a vital role in neuronal communication.
In terms of market performance, Spravato has seen a remarkable 60% increase in sales, totaling $271 million in the second quarter of 2023 compared to the same timeframe last year. The medication has benefited approximately 100,000 patients across 77 countries.
In summary, Johnson & Johnson’s initiative to propose Spravato as a standalone treatment marks a significant advancement in addressing the urgent needs of those battling treatment-resistant depression. This innovative approach showcases the potential for enhanced therapeutic options and could provide hope and relief for many patients who have struggled to find effective treatments.