Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, for treatment-resistant depression as a standalone therapy.
Originally approved by the FDA in 2019, Spravato was initially designated for use alongside an oral antidepressant in patients who did not respond to two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the prolonged struggle many patients face with ineffective treatments that significantly impact their daily lives and the lives of their loved ones.
The recent application is supported by data from a late-stage clinical trial, which indicated that Spravato effectively relieved patients’ symptoms within 24 hours of treatment and continued to do so for at least four weeks.
Administered as a nasal spray, Spravato requires supervision by a healthcare provider at a healthcare facility. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances levels of glutamate, which is crucial for neuronal communication.
In financial reports, Johnson & Johnson revealed that sales of Spravato surged by 60%, reaching $271 million in the second quarter of 2023 compared to the same time last year. The medication has been utilized by approximately 100,000 individuals across 77 countries.