Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) aimed at expanding the usage of its ketamine-based drug, Spravato. The company seeks to have it approved as a standalone therapy for individuals suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for patients whose symptoms failed to improve after trying two or more different antidepressants. Johnson & Johnson revealed that about 30 percent of the estimated 280 million people globally living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles faced by patients with hard-to-treat depression, noting that many endure prolonged periods trying numerous ineffective treatments. This cycle can impose significant emotional and functional burdens on both patients and their families.
The application to the FDA included results from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, could alleviate symptoms within 24 hours of administration and maintain effectiveness 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 environment. Unlike traditional antidepressants that target brain chemicals such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuron communication.
Sales of Spravato surged by 60% to $271 million in the second quarter of 2023 compared to the same period the previous year. According to Johnson & Johnson, Spravato has been utilized by approximately 100,000 individuals across 77 countries.