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	<title>mental health &#8211; FDAReview.org</title>
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		<title>FDA Panel Backs Ketamine-Based Treatment for Depression</title>
		<link>https://www.fdareview.org/2019/03/01/fda-panel-backs-ketamine-based-treatment-for-depression/</link>
		
		<dc:creator><![CDATA[Raymond March]]></dc:creator>
		<pubDate>Fri, 01 Mar 2019 17:00:53 +0000</pubDate>
				<category><![CDATA[Blog]]></category>
		<category><![CDATA[esketamine]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[mental health]]></category>
		<category><![CDATA[regulation]]></category>
		<category><![CDATA[treatment-resistant depression]]></category>
		<guid isPermaLink="false">http://www.fdareview.org/?p=328</guid>

					<description><![CDATA[New hope for depression patients may be on the horizon. A recent WebMD article reports that a special panel of experts assembled by the U.S. Food and Drug Administration strongly endorsed a new drug to help patients with treatment-resistant depression (a form of depression resilient to many anti-depressants). This new drug, named esketamine, also provides [&#8230;]]]></description>
										<content:encoded><![CDATA[<p>New hope for depression patients may be on the horizon.</p>
<p>A recent <em>WebMD</em> <a href="https://www.webmd.com/depression/news/20190213/fda-panel-backs-ketamine-like-drug-for-depression?fbclid=IwAR31SFUaKZvBEvL_SwmQeXSHe1kgVEozq2CX7VhrNjqxdVDhVWE2FrTWoGA">article</a> reports that a special panel of experts assembled by the U.S. Food and Drug Administration strongly endorsed a new drug to help patients with treatment-resistant<a href="https://www.mayoclinic.org/diseases-conditions/depression/in-depth/treatment-resistant-depression/art-20044324"> depression</a> (a form of depression resilient to many anti-depressants). This new drug, named esketamine, also provides an unprecedented ability to take effect within <a href="https://www.webmd.com/depression/news/20190213/fda-panel-backs-ketamine-like-drug-for-depression?fbclid=IwAR31SFUaKZvBEvL_SwmQeXSHe1kgVEozq2CX7VhrNjqxdVDhVWE2FrTWoGA">days</a> whereas others require months.</p>
<p>With nearly <a href="https://www.webmd.com/depression/news/20190213/fda-panel-backs-ketamine-like-drug-for-depression?fbclid=IwAR31SFUaKZvBEvL_SwmQeXSHe1kgVEozq2CX7VhrNjqxdVDhVWE2FrTWoGA">30 percent</a> of Americans experiencing depression at some point in their lives, and with the sporadic success of currently available treatment options, esketamine has tremendous potential to help millions manage their depression. As UCLA assistant professor of psychiatry Walter Dunn, who served on the panel, <a href="https://www.nbcnews.com/health/mental-health/new-depression-drug-related-ketamine-recommended-fda-panel-n970836">expressed</a>, “I think esketamine has the potential to be a game-changer in the treatment of depression.”</p>
<p>Despite its exciting potential, esketamine is receiving significantly more attention for being <a href="https://www.cnn.com/2019/02/12/health/esketamine-depression-fda-bn/index.html">similar to the street drug ketamine</a> (if you couldn’t tell by its name). Ketamine, sometimes referred to as “Special K” or “K,” is a street drug taken for its hallucinogenic effects. The Drug Enforcement Agency currently <a href="https://www.dea.gov/drug-scheduling">lists</a> ketamine as a Schedule III substance, containing both potential to cause psychological harm but also provide medical benefits. Regardless, it remains a controlled substance and largely reaches the public only through illicit means.</p>
<p>But ketamine’s reputation as a dangerous street drug runs counter to its reputation in medical literature. Indeed, knowledge of ketamine’s therapeutic abilities to combat depression dates back much further than recent developments. A 2014<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4243034/"> paper</a> published in <em>Current Neuropharmacology</em> reviews twenty-four previous academic publications (some dating back twenty years) and finds “ketamine may be considered a valid and intriguing antidepressant option for the treatment of TRD (treatment-resistant depression).”</p>
<p>Unfortunately, government restrictions that hinder the adoption of pioneering medical science are commonplace. As I’ve noted in a <a href="http://blog.independent.org/2018/06/19/fda-moves-closer-to-approving-ecstasy/">previous <em>Beacon</em> post</a>, ecstasy is currently classified as a Schedule I substance by the DEA, deemed to have no medicinal benefits. However, ecstasy is also expected to be approved by the FDA to treat Post-Traumatic Stress Disorder (PTSD) <a href="https://www.popsci.com/fda-just-approved-final-stage-mdma-drug-trials">by 2021</a>. Marijuana is also a Schedule I substance, but <a href="http://www.governing.com/gov-data/safety-justice/state-marijuana-laws-map-medical-recreational.html">33 states</a> have passed legislation granting patient access for medicinal purposes. Further, the FDA has <a href="https://www.statnews.com/2018/06/25/fda-approves-countrys-first-medicine-made-from-marijuana/">approved marijuana-based medication</a> to treat epilepsy.</p>
<p>The FDA will likely decide in early March whether it will allow esketamine to advance in its drug approval process. Despite widespread support of the panel (which voted 14-2 in favor), the agency may not heed its advice.</p>
<p>Considering the seriousness and pervasiveness of depression, as well as the history of medical professionals to find appropriate uses of drugs (even potentially dangerous ones), I hope the FDA allows esketamine to advance. Despite ketamine’s reputation, trusting scientists rather than government regulation is the safer bet.</p>
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