Johnson & Johnson announced on Monday that it has applied 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.
Spravato was first approved by the FDA in 2019 to be used in combination with an oral antidepressant for patients whose symptoms did not improve with two or more antidepressants.
Johnson & Johnson noted that nearly 30 percent of the estimated 280 million people worldwide with major depressive disorder suffer from treatment-resistant depression.
“Many patients with difficult-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, leading to significant functional and emotional burdens on patients and their loved ones,” said Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application includes data from a late-stage clinical trial indicating that Spravato, as a standalone treatment, helped alleviate patients’ symptoms as early as 24 hours after treatment, with effects lasting 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 setting. Unlike other antidepressants that regulate brain chemicals like serotonin and dopamine, Spravato works by boosting glutamate, the brain’s most abundant neurotransmitter, which facilitates neuron communication.
Sales of Spravato surged 60% to $271 million in the three months ending June 30, compared to the same period the previous year. According to Johnson & Johnson, Spravato has been used by 100,000 people in 77 countries.