Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the indication of its ketamine-based drug Spravato, allowing it to be used as a standalone therapy for treatment-resistant depression.
Spravato received FDA approval in 2019 for use alongside an oral antidepressant in patients whose symptoms do not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggle many patients face when dealing with difficult-to-treat depression, stating that they often spend excessive time trying various ineffective treatments, leading to significant emotional and functional burdens for themselves and their families.
The application includes data from a late-stage clinical trial that demonstrated Spravato’s effectiveness as a standalone treatment, with results showing symptom relief as early as 24 hours post-treatment and lasting for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that target chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is crucial for neuron communication.
In terms of sales, Spravato saw a 60% increase, totaling $271 million for the three-month period ending June 30, compared to the same timeframe in 2023. The drug has been utilized by approximately 100,000 patients across 77 countries, as reported by Johnson & Johnson.