Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was initially meant to be administered alongside an oral antidepressant for patients whose symptoms failed to improve with two or more antidepressant treatments.
According to Johnson & Johnson, approximately 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, noted in a press release that many patients with difficult-to-treat depression often spend excessive time trying various treatments that do not alleviate their symptoms, creating a considerable emotional and functional burden for them and their families.
The application was backed by data from a late-stage clinical trial, which indicated that Spravato, as an independent treatment, was effective in alleviating patient symptoms within just 24 hours and sustained improvements for at least four weeks.
Spravato is administered as a nasal spray and must be taken in a healthcare setting under the watchful eye of a healthcare provider. Unlike traditional antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, a vital neurotransmitter that plays a role in neuron communication.
Spravato’s sales increased significantly, rising by 60% to reach $271 million in the three-month period ending June 30, compared to the same quarter in 2023. The drug has been utilized by over 100,000 individuals across 77 countries, according to Johnson & Johnson.