FDA Approves Esketamine as Monotherapy for Treatment-Resistant Depression
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for esketamine CIII nasal spray (marketed as Spravato) as monotherapy for major depressive disorder (MDD) in adults who haven’t responded significantly to at least 2 oral antidepressants.
The approval is particularly significant, as it designates the nasal spray as the “first and only” monotherapy for treatment-resistant depression (TRD) in adults. It is estimated that 21 million US adults have experienced at least one major depressive episode, with approximately one-third of patients unresponsive to oral antidepressants.
“Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them. For too long, health care providers have had few options to offer patients much-needed symptom improvement,” said Bill Martin, PhD, Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine, via press release. Dr Martin is hopeful about esketamine being available as a standalone treatment because “patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days—without the need for daily oral antidepressants.”
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The application—which was also granted Priority Review—is supported by positive results from a randomized, double-blind, multicenter, placebo-controlled study. In this study, esketamine CIII nasal spray “alone showed a rapid and superior improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total score versus placebo. At day 28, patients receiving the nasal spray “demonstrated numerical improvement” across all MADRS items. Additionally, 22.5% of patients taking esketamine CIII nasal spray achieved remission of depression, versus just 7.6% of patients receiving placebo.
“For more than 6 years, I’ve seen firsthand the real-world impact Spravato can have on patients’ lives,” said Gregory Mattingly, MD, president of Midwest Research Group and Psych Congress Steering Commitment member. “Now that it is also available as a monotherapy, health care providers have the freedom to further personalize treatment plans based on individual needs, so patients can experience the efficacy of Spravato in as little as 24 hours, through day 28, without the need for a daily oral antidepressant.”
Serious side effects from esketamine may include increased blood pressure, problems with thinking clearly, bladder problems, among other common side effects like nausea, sleepiness, and headache. Most side effects occur immediately after esketamine administration and resolve the same day.
Intranasal esketamine also raises concerns about potential misuse, abuse, and diversion. For this reason, the medication is “only available through a restricted program called the Spravato Risk Evaluation and Mitigation Strategy (REM) Program.”
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