{"id":7108,"date":"2024-05-31T17:11:23","date_gmt":"2024-05-31T17:11:23","guid":{"rendered":"https:\/\/medexperts.pro\/?p=7108"},"modified":"2024-05-31T17:26:18","modified_gmt":"2024-05-31T17:26:18","slug":"fda-reviews-mdma-therapy-for-ptsd-citing-health-risks-and-study-flaws","status":"publish","type":"post","link":"https:\/\/medexperts.pro\/?p=7108","title":{"rendered":"FDA Reviews MDMA Therapy for PTSD, Citing Health Risks and Study Flaws"},"content":{"rendered":"
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The agency\u2019s staff analysis suggests that approval of the illegal drug known as Ecstasy for treatment of PTSD is far from certain, with advisers meeting next week to consider the proposed therapy.<\/p>\n

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The Food and Drug Administration on Friday raised concerns about the health effects of MDMA as a treatment for post-traumatic stress disorder, citing flaws in a company\u2019s studies that could pose major obstacles to approval of a treatment anticipated to help people struggling with the condition.<\/p>\n

The agency said<\/a> that bias had seeped into the studies because participants and therapists were readily able to figure out who got MDMA versus a placebo. It also flagged \u201csignificant increases\u201d in blood pressure and pulse rates that could \u201ctrigger cardiovascular events.\u201d<\/p>\n

The staff analysis was conducted for an independent advisory panel that will meet Tuesday to consider an application by Lykos Therapeutics for the use of MDMA-assisted therapy. The agency\u2019s concerns highlight the unique and complex issues facing regulators as they weigh the therapeutic value of an illegal drug commonly known as Ecstasy that has long been associated with all-night raves and cuddle puddles.<\/p>\n

Approval would mark a seismic change in the nation\u2019s tortuous relationship with psychedelic compounds, most of which the Drug Enforcement Administration classifies as illegal substances that have \u201cno currently accepted medical use and a high potential for abuse.\u201d<\/p>\n<\/div>\n<\/div>\n

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Research like the current studies on MDMA therapy have corralled the support of various groups and lawmakers from both parties for treatment of PTSD, a condition affecting millions of Americans, especially military veterans who face an outsize risk of suicide. No new therapy has been approved for PTSD in more than 20 years.<\/p>\n

\u201cWhat\u2019s happening is truly a paradigm shift for psychiatry,\u201d said David Olson, director of the U.C. Davis Institute for Psychedelics and Neurotherapeutics. \u201cMDMA is an important step for the field because we really lack effective treatments, period, and people need help now.\u201d<\/p>\n

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The agency\u2019s staff analysis suggests that approval of the illegal drug known as Ecstasy for treatment of PTSD is far from certain, with advisers meeting next week to consider the proposed therapy.The Food and Drug Administration on Friday raised concerns about the health effects of MDMA as a treatment for post-traumatic stress disorder, citing flaws in a company\u2019s studies that could pose major obstacles to approval of a treatment anticipated to help people struggling with the condition.The agency said that bias had seeped into the studies because participants and therapists were readily able to figure out who got MDMA versus a placebo. It also flagged \u201csignificant increases\u201d in blood pressure and pulse rates that could \u201ctrigger cardiovascular events.\u201dThe staff analysis was conducted for an independent advisory panel that will meet Tuesday to consider an application by Lykos Therapeutics for the use of MDMA-assisted therapy. The agency\u2019s concerns highlight the unique and complex issues facing regulators as they weigh the therapeutic value of an illegal drug commonly known as Ecstasy that has long been associated with all-night raves and cuddle puddles.Approval would mark a seismic change in the nation\u2019s tortuous relationship with psychedelic compounds, most of which the Drug Enforcement Administration classifies as illegal substances that have \u201cno currently accepted medical use and a high potential for abuse.\u201dResearch like the current studies on MDMA therapy have corralled the support of various groups and lawmakers from both parties for treatment of PTSD, a condition affecting millions of Americans, especially military veterans who face an outsize risk of suicide. No new therapy has been approved for PTSD in more than 20 years.\u201cWhat\u2019s happening is truly a paradigm shift for psychiatry,\u201d said David Olson, director of the U.C. Davis Institute for Psychedelics and Neurotherapeutics. \u201cMDMA is an important step for the field because we really lack effective treatments, period, and people need help now.\u201dWe are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and\u00a0log into\u00a0your Times account, or\u00a0subscribe\u00a0for all of The Times.Thank you for your patience while we verify access.Already a subscriber?\u00a0Log in.Want all of The Times?\u00a0Subscribe.<\/p>\n","protected":false},"author":1,"featured_media":7110,"comment_status":"close","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-7108","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-lifestyle"],"_links":{"self":[{"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts\/7108","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=7108"}],"version-history":[{"count":2,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts\/7108\/revisions"}],"predecessor-version":[{"id":7111,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts\/7108\/revisions\/7111"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/media\/7110"}],"wp:attachment":[{"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7108"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=7108"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=7108"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}