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The U.S. Food and Drug Administration (FDA) has approved Spravato (esketamine) CIII nasal spray for adults with major depressive disorder who have not responded adequately to at least two different oral antidepressants. This approval marks a significant advancement in the treatment of treatment-resistant depression, a condition that affects millions of people worldwide.
Spravato is the first and only approved monotherapy for this condition. Its approval, granted through the FDA’s priority review pathway, was based on positive results from a clinical trial. Patients treated with Spravato showed improvements across various depression symptoms compared to those receiving a placebo. Notably, 22.5% of patients on Spravato achieved remission, a significant improvement over the 7.6% remission rate observed in the placebo group.
Spravato targets the neurotransmitter glutamate, though the exact mechanism of its antidepressant action remains unclear. However, its rapid onset of action – with symptom improvements observed within 24 hours – offers a new hope for patients who have struggled with treatment-resistant depression.
Safety Considerations
To ensure safe and appropriate use, Spravato is available only through a restricted program. This is due to potential risks such as sedation, dissociation, respiratory depression, and the possibility of abuse and misuse. The medication must be administered by a healthcare provider in a supervised healthcare setting.
A New Hope for Patients
“Treatment-resistant depression can be incredibly challenging for patients,” said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. “For too long, healthcare providers have had limited options for patients who don’t respond to or cannot tolerate oral antidepressants. Spravato offers a new treatment option with the potential for rapid symptom improvement.”
Disclaimer: This news article is for informational purposes only and should not be considered medical advice. Consult with a healthcare professional for any health concerns or before making any decisions regarding your health or treatment.
