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 treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 as a supplemental therapy alongside an oral antidepressant, designated for patients who did not experience improvement with two or more antidepressant medications. According to Johnson & Johnson, nearly 30% of the estimated 280 million people worldwide living with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients dealing with difficult-to-treat depression, stating that many endure long periods trying various ineffective treatments, which can lead to significant emotional and functional burdens on themselves and their families.
The FDA application is supported by findings from a late-stage clinical trial that demonstrated Spravato’s effectiveness as a standalone treatment, with symptom relief noted as quickly as 24 hours post-treatment and sustained for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical environment. Unlike traditional antidepressants that focus on modulating neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million during the quarter ending June 30, compared to the same period in 2023. The drug has been used by around 100,000 individuals across 77 countries, as reported by Johnson & Johnson.