Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-derived medication, Spravato, allowing it to be administered as a standalone treatment for individuals suffering from treatment-resistant depression.
Initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who did not respond to two or more antidepressants, Spravato addresses a pressing need. Johnson & Johnson noted that approximately 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the profound impact of this condition, explaining that many patients endure prolonged periods trying various treatments that fail to alleviate their symptoms, leading to significant burdens on their personal and social lives.
The FDA application is bolstered by data from a late-stage clinical trial indicating that Spravato can provide relief to patients within 24 hours of administration and continue to do so for at least four weeks. This nasal spray must be taken under medical supervision, distinguishing it from conventional antidepressants which primarily affect serotonin and dopamine levels. Instead, Spravato enhances glutamate levels in the brain, a critical neurotransmitter that facilitates neuronal communication.
Spravato’s market performance reflects its growing acceptance and effectiveness, with sales surging by 60% to $271 million in the second quarter of 2023 compared to the same period last year. The medication has been utilized by 100,000 patients across 77 countries, showcasing its global reach and impact.
This development offers hope for those battling treatment-resistant depression, as a standalone option could simplify access to effective care and improve patient outcomes. With the advancement of treatments like Spravato, the future looks promising for individuals seeking relief from the burdens of this challenging mental health condition.