{"id":75908,"date":"2024-02-13T21:00:01","date_gmt":"2024-02-13T21:00:01","guid":{"rendered":"https:\/\/one.sightlinemg.com\/navytimes\/uncategorized\/2024\/02\/13\/psychedelic-to-receive-fast-track-review-as-possible-ptsd-drug\/"},"modified":"2026-08-08T15:17:45","modified_gmt":"2026-08-08T15:17:45","slug":"psychedelic-to-receive-fast-track-review-as-possible-ptsd-drug","status":"publish","type":"post","link":"https:\/\/one.sightlinemg.com\/navytimes\/news\/your-navy\/2024\/02\/13\/psychedelic-to-receive-fast-track-review-as-possible-ptsd-drug\/","title":{"rendered":"Psychedelic to receive fast-track review as possible PTSD drug"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.militarytimes.com\/news\/your-military\/2023\/11\/08\/psychedelics-may-soon-be-available-sort-of-to-treat-vets-with-ptsd\/\" target=\"_blank\">Midomafetamine, or MDMA<\/a>, a form of molly or ecstasy that has increasingly been coupled with patient therapy to treat post-traumatic stress disorder, was approved recently for a fast-track review by the <a href=\"https:\/\/www.militarytimes.com\/off-duty\/military-culture\/2019\/03\/11\/lsd-and-magic-mushrooms-can-enhance-cognitive-capabilities-help-win-wars-study-claims\/\" target=\"_blank\">U.S. Food and Drug Administration<\/a>, according to a Feb. 9 announcement from Lykos Therapeutics.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The designation means the FDA will review the drug on a faster timeline \u2014 six months instead of 10 \u2014 and \u201cdirect overall attention and resources\u201d to the study of drugs that, if approved, would allow for \u201cimprovements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions,\u201d according to the FDA\u2019s website.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The FDA has a target date of Aug. 11 to conclude its evaluation of MDMA-assisted therapy. Lykos Therapeutics filed for the review.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u201cWe\u2019re grateful to those in Washington, D.C., who are working overtime to pave the way for [MDMA]\u2019s acceptance and approval,\u201d <a href=\"https:\/\/www.militarytimes.com\/newsletters\/2023\/12\/15\/first-ever-provision-for-psychedelic-studies-included-in-defense-bill\/\" target=\"_blank\">Juliana Mercer<\/a>, director of veteran advocacy for the group Healing Breakthrough, said in a statement. \u201cThe federal government is putting skin in the game after decades of philanthropically-funded private research.\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The FDA in 2017 designated MDMA as a <a href=\"https:\/\/www.militarytimes.com\/news\/your-army\/2018\/05\/09\/psychedelic-drug-provides-relief-for-veterans-with-ptsd\/\" target=\"_blank\">\u201cbreakthrough therapy\u201d<\/a> for treatment of PTSD. Psilocybin to treat anxiety and depression received that designation in 2019.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Multidisciplinary Association of Psychedelic Studies, or MAPS, has researched the effects of MDMA for more than 30 years. It was tasked with conducting further studies on the treatment, the most recent of which was a multisite clinical trial and a second phase III trial.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In the second trial, more than 86% of participants who received the MDMA-assisted therapy for PTSD experienced \u201cclinically meaningful\u201d improvement 18 weeks after starting the trial, according to MAPS.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">More than 71% of participants who underwent MDMA-assisted therapy also no longer met the diagnostic criteria for PTSD at the end study, compared to little more than 46% of participants who had the placebo plus therapy.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The first-ever <a href=\"https:\/\/www.militarytimes.com\/newsletters\/2023\/12\/15\/first-ever-provision-for-psychedelic-studies-included-in-defense-bill\/\" target=\"_blank\">provision for psychedelic studies<\/a> was passed last year in the 2024 defense policy bill. Though yet to be passed, the Veterans Affairs appropriations bill would direct the department to set up pilot programs across the country for breakthrough therapies, including MDMA.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA wants to conclude its evaluation of MDMA-assisted therapy by Aug. 11.<\/p>\n","protected":false},"author":7,"featured_media":38124,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_yoast_wpseo_meta-robots-noindex":"","_yoast_wpseo_meta-robots-nofollow":"","_yoast_wpseo_canonical":"","_acf":"","_yoast_wpseo_primary_category":65,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","_smg_distribution_targets":[]},"categories":[101,23,12,26,65],"tags":[],"coauthors":[3313],"class_list":["post-75908","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-daily-news-roundup","category-home","category-news","category-newsletters","category-your-navy"],"acf":{"subheadline":"","legacy_arc_id":"HJQUPVCUSRHVBG4UZHLNNSYKPA","arc_canonical_url":"\/news\/your-military\/2024\/02\/13\/psychedelic-to-receive-fast-track-review-as-possible-ptsd-drug\/","remove_feature_photo":false,"is_sponsored":false,"subtype":"","redirect_url":"","disable_inline_ads":false,"native_logo_pretext":"Presented 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