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, for standalone therapy aimed at treating resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms failed to improve with two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggle many patients face with difficult-to-treat depression, stating that they often spend excessive time trying various treatments that do not alleviate their symptoms, resulting in significant emotional and functional burdens on both patients and their families.
The application to the FDA is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, significantly alleviated symptoms in patients as quickly as 24 hours post-treatment and maintained effectiveness for at least four weeks.
Administered as a nasal spray, Spravato must be taken under the supervision of a healthcare professional within a medical setting. Unlike traditional antidepressants that modify brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels, the brain’s most prevalent neurotransmitter, facilitating effective neuron communication.
Sales of Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same quarter in 2023. Johnson & Johnson reported that the medication has been utilized by 100,000 patients across 77 countries.