February 25, 2025Spravato, the esketamine nasal spray approved in 2019 for use alongside oral antidepressants for treatment-resistant depression, has been approved by the U.S.

Food and Drug Administration (FDA) as a standalone monotherapy with no oral medication required.Esketamine is a form of the dissociative agent ketamine, commonly used as an anesthetic; it works by targeting the neurotransmitter glutamate.

According to a randomized, double-blind, placebo-controlled study, 22.5% of patients who took Spravato alone for four months achieved remission from depression (as measured by MADRS) compared with 7.6% of patients taking placebo.1Common side effects in clinical trials were disassociation, dizziness, nausea or vomiting, sedation, headache, decreased sensitivity, anxiety, increased blood pressure, and feeling of intoxication.

Due to these potential risks, the treatment is available only through the Risk Evaluation and Mitigation Strategy Program and must be self-administered in certified health care settings.

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United States	Cases: 46 252 513 Deaths: 750 423 Recovered: 0
India	Cases: 34 321 025 Deaths: 459 652 Recovered: 0
Brazil	Cases: 21 835 785 Deaths: 608 235 Recovered: 0
United Kingdom	Cases: 9 215 683 Deaths: 141 607 Recovered: 0
Russia	Cases: 8 494 589 Deaths: 237 619 Recovered: 0

Spravato Approved for Treatment-Resistant Depression

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