Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to extend the approved use of its ketamine-based drug, Spravato, now seeking to make it available as a standalone treatment for individuals with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was initially recommended for use in conjunction with an oral antidepressant for patients who did not see improvement after trying two or more different antidepressants. According to Johnson & Johnson, nearly 30% of the 280 million individuals globally living with major depressive disorder struggle with treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the struggle many patients face with chronic depression, explaining that they often endure lengthy cycles of trying various ineffective treatments. This can lead to significant emotional and functional difficulties not only for the individual but also for their families.
The application to the FDA is bolstered by positive data from a late-stage clinical trial, which demonstrated that Spravato can alleviate symptoms as quickly as 24 hours after administration and maintains effectiveness for at least four weeks. This nasal spray is administered under healthcare supervision and operates by enhancing glutamate levels in the brain, rather than the more common serotonin and dopamine pathways targeted by other antidepressants.
Sales of Spravato have seen a significant increase, rising 60% to $271 million in the second quarter of 2023 compared to the same period last year. The drug has been utilized by approximately 100,000 people across 77 countries.
This development is promising for those facing the challenging impacts of treatment-resistant depression, potentially providing a new avenue for relief that may soon be more accessible to patients in need. The advances in treatment options signify a hopeful future for improved mental health care.