Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based drug, Spravato. The company is looking to have Spravato approved as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use in combination with an oral antidepressant for patients who had not found relief from two or more antidepressants. Johnson & Johnson noted that 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, stated that many patients dealing with difficult-to-treat depression often spend excessive time going through various treatments that fail to alleviate their symptoms, resulting in a significant emotional and functional burden for both patients and their families.
The application to the FDA was backed by data from late-stage clinical trials, which revealed that Spravato, when used as a standalone treatment, showed symptom improvement as early as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike standard antidepressants, which typically target neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and plays a crucial role in neuron communication.
The sales revenue for Spravato surged 60% to $271 million in the three months ending June 30, compared to the same time frame in 2023. The drug has been utilized by approximately 100,000 patients across 77 countries, as reported by Johnson & Johnson.