In March, the FDA approved Janssen Pharmaceuticals’ depression drug esketamine, a form of ketamine for use as a treatment for depression. Billed as the most exciting antidepressant in decades, the drug has an entirely new mechanism of action. So what does esketamine offer, and why is the FDA so sure the benefits outweigh the risks? Abi Millar reports.
In March 2019, the US Food and Drug Administration (FDA) approved Spravato (esketamine) nasal spray, for patients with treatment resistant depression (TRD). This medication, developed by Janssen Pharmaceuticals, is a first-in-class therapy and the first new antidepressant to be approved in 20 years.
“Esketamine is the first truly novel antidepressant since fluoxetine. It is only the second drug approved to treat treatment-resistant depression,” says Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The esketamine development program received Breakthrough Therapy Designation based on preliminary evidence that it could provide an advantage over existing therapy for TRD.”
The need for such a drug is clear. Depression is one of the most common, and most debilitating, mental health problems out there. In the US, 17.3 million adults had at least one major depressive episode in 2017 (or around 7% of the population).
For many of these people, existing treatments work well, with antidepressant medications setting them on the road to recovery. Unfortunately, a significant minority do not respond to medication at all. Among patients with major depressive disorder (MDD), it is thought that up to a third are treatment resistant.
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