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-based medication, Spravato, allowing it to be used as a stand-alone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients who had not seen improvements after trying two or more antidepressants.
Johnson & Johnson noted that nearly 30% of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the issue, stating that many patients endure prolonged periods trying various treatments that fail to alleviate their symptoms, resulting in both functional and emotional distress for them and their families.
The application includes data from a late-stage clinical trial indicating that Spravato as a stand-alone treatment significantly reduced patients’ symptoms as early as 24 hours after administration and maintained improvements 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 enhances glutamate levels in the brain, which is essential for neuron communication.
Sales of Spravato increased by 60%, reaching $271 million in the quarter ending June 30, compared to the same quarter in 2023. The drug has been utilized by approximately 100,000 patients across 77 countries, according to Johnson & Johnson.