Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. Approximately 30% of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression, according to Johnson & Johnson.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients grappling with difficult-to-treat depression often go through numerous treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for both patients and their families.
The application was supported by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, showed symptom relief in patients within 24 hours and sustained benefits for at least four weeks.
Administered as a nasal spray, Spravato must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants, which typically target neurotransmitters like serotonin and dopamine in the brain, Spravato enhances glutamate levels. Glutamate, being the most plentiful neurotransmitter in the brain, plays a vital role in neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same period in 2023. According to Johnson & Johnson, Spravato has been utilized by 100,000 patients in 77 countries.