Earlier this month, the U.S. Food and Drug Administration approved Spravato, an esketamine nasal spray, for treating depression in adults with treatment-resistant depression in conjunction with an oral antidepressant.
This is exciting news for patients with major depressive disorder who, despite having been given adequate doses of at least two antidepressant treatments for an adequate duration, have not responded to treatment.
"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," wrote Tiffany Farchione, MD, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, in a release announcing the approval.
But the approval was not surprising to those who have been participating in the controlled clinical trials leading up to that approval, said Mike Good, director of Research for Ascension Via Christi Research.
“We participated in two study protocols designed to prove the safety and effectiveness of this compound and were one of the top-enrolling sites in the United States for these studies,” says Good. “Major depressive disorder, or MDD, is a disabling disorder that can render patients bedridden and unable to work or fulfill any meaningful life activities. We saw some amazing results among the patients we enrolled in the trials.”
Esketamine, is the s-enantiomer of ketamine, a mixture of two mirror image molecules that was first FDA-approved in 1970; this month’s approval by the FDA of esketamine for treating MDD was the first for any use. Janssen Pharmaceuticals' application for approval was granted through the FDA's Fast Track and Breakthrough Therapy designations.
Psychiatrist Paul Murphy, MD, was the principal investigator for the studies conducted by Ascension Via Christi Research and Janie Krull, APRN, was the sib-investigator. “This breakthrough is the first advancement in the treatment of major depression in the past two decades,” says Dr. Murphy. “Going forward, this agent looks promising for the millions of Americans who suffer from depression.