Esketamine: Antidepressant approved by FDA for MDD

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Recently, the Food and Drug Administration (FDA) approved of esketamine, a drug for major depressive disorder. Sold under the brand name Spravato, this antidepressant was eagerly anticipated by psychiatrists around the globe.

Developed by Janssen Pharmaceutica, this drug provides a new mechanism of action after 30 years. The nasal spray acts within hours. Certainly, this is amazing as compared to other drugs that take weeks to months. Esketamine could offer a lifeline to millions of people who are suffering from treatment-resistant depression.

More doctors are using ketamine to treat severe depression in patients who haven’t responded to other treatments.

Jeffrey Lieberman, a psychiatrist from Columbia University, stated that this is undeniably a major advancement. However, much about this drug is not known. As a result of which, the label for this drug will contain a black box warning. A boxed warning is the FDA’s most serious warning pertaining to a drug.

GUIDELINES BY FDA

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I believe that if you were to intake the drug, you must know about the strict guidelines that it came along with. The nasal spray is available only through REMS (Risk Evaluation and Mitigation Strategy). Firstly, both you and your doctor have to sign a patient enrollment form. The form states that you understand that you need to have help safely leaving your doctor’s office. Secondly, you won’t drive or operate heavy machinery the day after you use the drug. The doctor must give the drug in their office under medical supervision.

People who take esketamine have to undergo two hours of monitoring. This is to ensure that side effects do not take place. As of now, take the drug is to be taken an oral antidepressant.

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