Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be used as a standalone treatment for patients with treatment-resistant depression.
Spravato was originally approved by the FDA in 2019 for use alongside an oral antidepressant, specifically for patients who had not seen improvement after trying two or more other antidepressants.
The company noted that nearly 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggle many patients face, often enduring prolonged periods with ineffective treatments, which adds considerable emotional and functional strain on both the patients and their families.
The application was supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, was able to alleviate symptoms in patients as quickly as 24 hours post-treatment, with effects lasting for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike typical antidepressants that target neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, the most prevalent neurotransmitter responsible for neuronal communication.
Sales for Spravato increased by 60% to $271 million in the second quarter of 2023 compared to the same period last year. Johnson & Johnson reported that the medication has already been prescribed to 100,000 individuals across 77 countries.