28 January 2025

FDA Expands Approval of Spravato Nasal Spray for Major Depressive Disorder

Major depressive disorder (MDD) is the most commonly diagnosed mental health condition worldwide, with the number of cases increasing annually. Currently, hundreds of millions of people live with MDD, and past studies reveal that only 30% achieve full remission with a single antidepressant, while 50% experience no response at all.

Dr. Gregory Mattingly, a principal investigator with the Midwest Research Group and founding partner of St. Charles Psychiatric Associates, noted that depression rates in the United States have nearly doubled in the past two decades. He highlighted that around 21 million adults in the U.S. experience at least one major depressive episode, with a third facing treatment-resistant depression. MDD not only impacts individuals but also places a significant emotional and economic strain on families and society, making it one of the costliest psychiatric disorders.

In response to this challenge, the Food and Drug Administration (FDA) has expanded the approval of Spravato (esketamine), a nasal spray developed by Johnson & Johnson. Initially approved in 2019, Spravato is now authorized for adults with MDD who have not responded to at least two oral antidepressants. This innovative treatment offers new hope for those struggling with hard-to-treat depression.