Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant specifically for patients whose conditions did not improve after trying two or more antidepressant medications.
Johnson & Johnson highlighted that nearly 30 percent of the approximately 280 million individuals globally affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the challenges faced by patients dealing with difficult-to-treat depression. He noted that these patients often endure prolonged periods trying multiple treatments that may not adequately improve their symptoms, resulting in significant emotional and functional distress for both themselves and their families.
The application to the FDA included data from a late-stage clinical trial that demonstrated Spravato’s effectiveness as a standalone treatment, with patients experiencing symptom relief as soon as 24 hours after the first dosage and maintaining benefits for at least four weeks of treatment.
Spravato, which is administered through a nasal spray, must be taken in a healthcare setting under professional supervision. Unlike traditional antidepressants that primarily affect neurotransmitters such as serotonin and dopamine, Spravato enhances the levels of glutamate in the brain, which is the most prevalent neurotransmitter and is crucial for neuronal communication.
Sales of Spravato surged by 60% to $271 million in the second quarter of 2023, compared to the same period in the previous year. To date, Spravato has been utilized by around 100,000 patients across 77 countries, as reported by Johnson & Johnson.