The US Food and Drug Administration (FDA) has expanded the use of esketamine nasal spray (Spravato) to include treatment of major depressive disorder as a standalone therapy for adults who haven't responded adequately to at least two oral antidepressants. The decision is based on a clinical trial showing rapid and superior improvement in depression symptoms with esketamine compared to placebo.
The US Food and Drug Administration has approved a supplemental new drug application allowing esketamine nasal spray to be used as a standalone treatment in adults with major depressive disorder who have not responded adequately to at least two oral antidepressants.
“For more than 6 years, I’ve seen firsthand the real-world impact Spravato can have on patients’ lives,” Gregory Mattingly, MD, with St. Charles Psychiatric Associates and Midwest Research Group, St. Charles, Missouri, said in the release.
Major Depressive Disorder Esketamine FDA Approval Spravato Monotherapy
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