New Depression Treatment Nears FDA Approval Leave a comment


(RxWiki News) Written by Anyssa Garza, PharmD, BCMAS

Esketamine is considered the first big depression advance since the approval of Prozac — and it’s nearing approval for treatment-resistant depression.

Dozens of antidepressants have been approved over the years. These include Eli Lilly’s “blockbuster” drug Prozac, which was approved in 1987. But there haven’t been any new advancements in other types of antidepressants that work in different ways.

If approved, Spravato (esketamine), a nasal spray to treat treatment-resistant depression, would offer the first new mechanism of action in 30 years to treat major depressive disorder (MDD).

Currently, esketamine is an investigational treatment that is believed to work differently than the current antidepressants available on the market.

This medication’s fate was decided on Feb. 12, when a US Food and Drug Administration (FDA) advisory committee met to vote on esketamine. The vote was 15 to 2 in favor of esketamine’s safety profile and 14 to 2 (1 abstained) in regard to esketamine’s benefits when compared to its risks.

Johnson & Johnson’s esketamine is very close in structure to ketamine, which is known as a psychedelic club drug. Currently, esketamine is approved to be used as anesthesia.

The esketamine being voted on is available as a 28-milligram, single-use nasal spray.

Side effects tied to this medication may include high blood pressure, drowsiness and disassociation (an out-of-body experience). The FDA is recommending a Risk Evaluation and Mitigation Strategy (REMS) to ensure patient safety. Those who receive this medication are to be monitored for two hours after, the medication will only be given in certain health care settings, it will not be dispensed directly to patients and patients will be enrolled in a registry.

The decision on whether to allow this medication on the market is expected to be released March 4.



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