Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to extend the approved use of its ketamine-based drug, Spravato, to function as a standalone therapy for individuals suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 to be used in conjunction with an oral antidepressant for patients who did not see improvement after trying two or more different antidepressants. The pharmaceutical giant notes that nearly 30% of the estimated 280 million individuals globally who experience major depressive disorder face the challenges of treatment-resistant depression.
Bill Martin, Johnson & Johnson’s head of neuroscience, highlighted the urgent need for better treatment options, stating that many patients struggle while trying multiple treatments that often fail to alleviate their symptoms, leading to substantial emotional and functional burdens both for patients and their families.
The application submitted to the FDA is backed by data from a late-stage clinical trial, which indicated that when used on its own, Spravato showed an ability to alleviate symptoms within just 24 hours of administration and maintained this effect for at least four weeks.
Spravato is administered via nasal spray and must be taken under the supervision of a healthcare provider in a controlled setting. Unlike traditional antidepressants that primarily influence neurotransmitters like serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a vital role in neuron communication.
The financial performance of Spravato has been impressive, with sales increasing by 60% to $271 million for the quarter ending June 30 compared to the same period in 2023. Spravato has reached approximately 100,000 patients across 77 countries, reflecting its growing acceptance and usage.
This development marks a significant step forward in mental health treatment options, as the potential approval of Spravato as a standalone therapy could offer renewed hope for many individuals battling treatment-resistant depression, thereby enhancing their quality of life.