Johnson & Johnson (J&J) 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 medication, Spravato. The company aims for Spravato to be recognized as a standalone therapy for treatment-resistant depression.
This application seeks to enhance the capabilities of Spravato, originally approved in 2019 for use in conjunction with an oral antidepressant for patients who did not respond to two or more antidepressant treatments. Johnson & Johnson highlighted that nearly 30% of the estimated 280 million individuals worldwide grappling with major depressive disorder are affected by treatment-resistant depression.
Bill Martin, J&J’s head of neuroscience, emphasized the urgency for improved treatment options, stating, “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.”
The application is supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, significantly alleviated symptoms as soon as 24 hours post-treatment and remained effective for at least four weeks. Spravato is administered via a nasal spray under the supervision of healthcare providers and offers a different mechanism of action compared to typical antidepressants, as it enhances glutamate levels in the brain instead of primarily focusing on serotonin and dopamine.
Sales of Spravato surged by 60% to $271 million in the second quarter of 2023 compared to the same timeframe last year, with over 100,000 individuals using the product across 77 countries.
This potential approval comes at a crucial time when effective treatment options for those with treatment-resistant depression are limited. With ongoing advancements and promising clinical trial results, there is hope that Spravato could provide significant relief for countless individuals struggling with this challenging condition. The expanding reach of innovative therapies like Spravato aligns with the growing commitment to addressing mental health issues on a global scale.