{"id":7258,"date":"2024-06-04T22:22:24","date_gmt":"2024-06-04T22:22:24","guid":{"rendered":"https:\/\/medexperts.pro\/?p=7258"},"modified":"2024-06-04T22:24:38","modified_gmt":"2024-06-04T22:24:38","slug":"fda-panel-rejects-use-of-mdma-for-treatment-of-ptsd","status":"publish","type":"post","link":"https:\/\/medexperts.pro\/?p=7258","title":{"rendered":"FDA Panel Rejects Use of MDMA for Treatment of PTSD"},"content":{"rendered":"
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An independent group of experts expressed concerns that the data from clinical trials did not outweigh risks for treatment of post-traumatic stress disorder.<\/p>\n

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An independent advisory panel of the Food and Drug Administration rejected the use of MDMA-assisted therapy for post-traumatic stress disorder on Tuesday, highlighting the unparalleled regulatory challenges of a novel therapy using the drug commonly known as Ecstasy.<\/p>\n

Before the vote, members of the panel raised concerns about the designs of the two studies submitted by the drug\u2019s sponsor, Lykos Therapeutics. Many questions focused on the fact that study participants were by and large able to correctly guess whether they had been given MDMA, also known by the names of Ecstasy or molly. <\/span><\/p>\n

The panel voted 9-2 on whether the MDMA-assisted therapy was effective, and voted 10-1 on whether the proposed treatment\u2019s benefits outweighed its risks.<\/p>\n

Other panelists expressed concerns over the drug\u2019s potential cardiovascular effects, and possible bias among the therapists and facilitators who guided the sessions and may have positively influenced patient outcomes. A case of misconduct involving a patient and therapist in the study also weighed on some panelists\u2019 minds.<\/p>\n<\/div>\n<\/div>\n

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Many of the committee members said they were especially worried about the failure of Lykos to collect detailed data from participants on the potential for abuse of a drug that generates feelings of bliss and well-being.<\/p>\n

\u201cI absolutely agree that we need new and better treatments for PTSD,\u201d said Paul Holtzheimer, deputy director for research at the National Center for PTSD, a panelist who voted no on the question of whether the benefits of MDMA-therapy outweighed the risks.<\/p>\n

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An independent group of experts expressed concerns that the data from clinical trials did not outweigh risks for treatment of post-traumatic stress disorder.An independent advisory panel of the Food and Drug Administration rejected the use of MDMA-assisted therapy for post-traumatic stress disorder on Tuesday, highlighting the unparalleled regulatory challenges of a novel therapy using the drug commonly known as Ecstasy.Before the vote, members of the panel raised concerns about the designs of the two studies submitted by the drug\u2019s sponsor, Lykos Therapeutics. Many questions focused on the fact that study participants were by and large able to correctly guess whether they had been given MDMA, also known by the names of Ecstasy or molly. The panel voted 9-2 on whether the MDMA-assisted therapy was effective, and voted 10-1 on whether the proposed treatment\u2019s benefits outweighed its risks.Other panelists expressed concerns over the drug\u2019s potential cardiovascular effects, and possible bias among the therapists and facilitators who guided the sessions and may have positively influenced patient outcomes. A case of misconduct involving a patient and therapist in the study also weighed on some panelists\u2019 minds.Many of the committee members said they were especially worried about the failure of Lykos to collect detailed data from participants on the potential for abuse of a drug that generates feelings of bliss and well-being.\u201cI absolutely agree that we need new and better treatments for PTSD,\u201d said Paul Holtzheimer, deputy director for research at the National Center for PTSD, a panelist who voted no on the question of whether the benefits of MDMA-therapy outweighed the risks.We 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":7260,"comment_status":"close","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-7258","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\/7258","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=7258"}],"version-history":[{"count":2,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts\/7258\/revisions"}],"predecessor-version":[{"id":7261,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts\/7258\/revisions\/7261"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/media\/7260"}],"wp:attachment":[{"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7258"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=7258"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=7258"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}