FDA OKs esketamine nasal spray monotherapy for resistant depression

An article in Medscape Psychiatry reports: "The US Food and Drug Administration (FDA) has approved a supplemental new drug application allowing esketamine nasal spray (Spravato; Johnson & Johnson) to be used as a standalone treatment in adults with major depressive disorder who have not responded adequately to at least two oral antidepressants.  The FDA first approved esketamine nasal spray for treatment-resistant depression in combination with an oral antidepressant, as reported by Medscape Medical News. The expanded indication as monotherapy is supported by a double-blind, randomized placebo-controlled trial that demonstrated “rapid and superior” improvement in Montgomery-Asberg Depression Rating Scale (MADRS) scores with esketamine nasal spray monotherapy compared with placebo, the company said in a news release. At 4 weeks, 22.5% of patients using esketamine nasal spray achieved remission (MADRS total score ≤ 12) compared with only 7.6% of patients using placebo ... The safety profile of esketamine nasal spray as a standalone treatment mirrors that when used with oral antidepressant medication, the company said.  The potential risk for serious adverse outcomes associated with the drug, including sedation and dissociation and the potential for abuse and misuse, means it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy."

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