Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was sanctioned for use in conjunction with an oral antidepressant for patients whose symptoms failed to improve with at least two other antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals globally living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the challenges faced by patients with difficult-to-treat depression, noting that many endure prolonged cycles of ineffective treatments that inflict significant emotional and functional burdens on both them and their families.
The company’s application is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can alleviate symptoms as soon as 24 hours after administration and maintain those effects for at least four weeks.
Spravato is administered via nasal spray and must be taken in a healthcare setting under the supervision of a healthcare provider. Unlike traditional antidepressants that impact neurotransmitters like serotonin and dopamine, Spravato increases levels of glutamate in the brain, a vital neurotransmitter for neuron communication.
Sales of Spravato saw a 60% increase, reaching $271 million for the three months ending June 30, compared to the same quarter in 2023. To date, the drug has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.