FDA Approves Spravato for Treatment-Resistant Depression in Adults
The U.S. Food and Drug Administration (FDA) has given its nod to the use of Spravato (esketamine) nasal spray for adults suffering from severe, treatment-resistant depression who have not responded to at least two oral antidepressants. This announcement was made in a press release by Johnson & Johnson, marking Spravato as the first FDA-approved standalone treatment for adults with this challenging condition.
According to McGovern Medical School, the approval came after an expedited review by the FDA, based on results from a randomized, double-blind, placebo-controlled, multicenter clinical trial. The results showed significant improvement across all ten items on the Montgomery-Åsberg Depression Rating Scale (MADRS) after 28 days of treatment. Notably, after four weeks, 22.5% of patients using Spravato showed marked improvement, compared to only 7.6% in the placebo group.
Spravato is administered under healthcare supervision in a medical setting, targeting the
neurotransmitter glutamate. Although the exact mechanism by which esketamine works as an
antidepressant is not fully understood, it has shown promise in rapidly alleviating symptoms of
depression.
To ensure safe and appropriate use,
Spravato is only available through a restricted program called the Spravato Risk Evaluation and
Mitigation Strategy (REMS) due to potential serious side effects like sedation, dissociation,
respiratory depression, and abuse.
Bill Martin, President of Global Neuroscience Therapeutics at Johnson & Johnson Innovative
Medicine, highlighted the complexity of treatment-resistant depression, especially for patients
who do not respond to or cannot tolerate oral antidepressants. “With Spravato now available as a
standalone treatment, patients might experience relief from depressive symptoms within 24
hours to 28 days, without the need for daily oral medications,” Martin stated.
This approval opens new avenues for healthcare providers who previously had limited options for
patients needing substantial symptom relief from this debilitating condition.
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