Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug Spravato to be used as a standalone therapy for treatment-resistant depression.
Originally approved in 2019, Spravato was intended to be used in combination with an oral antidepressant for patients whose symptoms did not improve with two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally living with major depressive disorder have treatment-resistant depression.
Bill Martin, Johnson & Johnson’s head of neuroscience, said, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
This new application is supported by data from a late-stage clinical trial that demonstrated Spravato’s effectiveness as a standalone treatment. It was shown to alleviate patients’ symptoms as early as 24 hours after treatment, with effects lasting 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 other antidepressants that regulate chemicals such as serotonin and dopamine, Spravato works by boosting glutamate levels in the brain, which is the most abundant neurotransmitter and aids in neuron communication.
Sales of Spravato surged 60% to $271 million in the three months ending June 30, 2023, compared to the same period the previous year. The drug has been used by 100,000 people across 77 countries, as reported by Johnson & Johnson.