{"id":1167556,"date":"2024-06-09T08:00:10","date_gmt":"2024-06-09T12:00:10","guid":{"rendered":"https:\/\/www.statnews.com\/?p=1167556"},"modified":"2024-06-10T10:33:52","modified_gmt":"2024-06-10T14:33:52","slug":"mdma-lykos-maps-psychedelics","status":"publish","type":"post","link":"https:\/\/www.statnews.com\/2024\/06\/09\/mdma-lykos-maps-psychedelics\/","title":{"rendered":"The inside story of how Lykos\u2019 MDMA research went awry"},"content":{"rendered":"<p>At a heated advisory committee meeting convened by the Food and Drug Administration last week, regulators repeatedly expressed frustration that Lykos, a company <a href=\"https:\/\/www.statnews.com\/2024\/06\/04\/fda-advisory-panel-mdma-therapy-ptsd\/\">seeking approval of MDMA-assisted therapy to treat PTSD<\/a>, failed to follow instructions and track positive feelings such as \u201ceuphoria\u201d that could be used to inform understanding of the drug\u2019s addiction potential.<\/p>\n<p>The missing data, said clinical reviewer David Millis, were \u201ca major concern.\u201d<\/p>\n<p>Lykos executives said they\u2019d simply misunderstood the FDA\u2019s instructions, but three former employees told a different story. The company was long aware it was required to collect such data, they said, and simply failed to do what was needed amid widespread disorganization. Employees described waiting in vain for a protocol to collect the data to be approved, while executives seemed distracted dealing with other problems.<\/p>","protected":false},"excerpt":{"rendered":"<p>There was mounting excitement about the FDA&#8217;s review of Lykos&#8217; MDMA-assisted therapy. But former employees said the company committed a series of lapses.<\/p>\n","protected":false},"author":453,"featured_media":1167373,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"stat_display_restriction_not_latest":false,"stat_featured_image_caption":"","stat_featured_image_nocrop":false,"stat_featured_image_focal_point":{"x":0.5,"y":0.5},"stat_article_wordmark_img":[],"stat_article_wordmark_url":"","stat_article_wordmark_height":"125px","stat_article_wordmark_enable":false,"stat_article_subheadline":"","stat_paywall_restrict":true,"footnotes":"","stat_article_enhanced_byline":"","stat_article_newsletter_id":"","stat_article_header_color_scheme":"","_yoast_wpseo_primary_category":2304,"stat_paywall_move_flag":0},"categories":[2304,54],"tags":[294,1047,202512,5393],"authors":[198346],"class_list":["post-1167556","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-exclusive","category-health","tag-fda","tag-mental-health","tag-psychedelics","tag-stat-plus"],"featured_image_src":"https:\/\/www.statnews.com\/wp-content\/uploads\/2024\/06\/ecstacy-04-1024x452.jpg","coauthors":[{"avatar":"<img width=\"80\" height=\"80\" src=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/olivia-g-avatar-small-80x80.png\" class=\"avatar\" alt=\"Olivia Goldhill\" loading=\"lazy\" sizes=\"auto, (max-width: 80px) 100vw, 80px\" decoding=\"async\" srcset=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/olivia-g-avatar-small-80x80.png 80w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/olivia-g-avatar-small-160x160.png 160w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/olivia-g-avatar-small.png 300w\" \/>","display_name":"Olivia Goldhill","author_page":"https:\/\/www.statnews.com\/staff\/olivia-goldhill\/","first_name":"Olivia","title":"Contributing Writer","bio":"Olivia Goldhill focused primarily on covering the health crisis affecting American boys and men. She also covered psychedelic medicines.","email_address":"olivia.goldhill@statnews.com","email_url":"mailto:olivia.goldhill@statnews.com","twitter_url":"https:\/\/x.com\/OliviaGoldhill","twitter_handle":"@OliviaGoldhill","facebook_url":"","linkedin_url":"","web_url":"","bluesky_url":"","bluesky_handle":""}],"stat_card_curation":{"image_id":1167373,"title":"","excerpt":"","video_id":0,"disable_topic_image_curation":false},"template_inline_styles":[],"stat_byline_classes":["article-byline","single-author"],"use_block_editor_for_post":false,"stat_featured_video":null,"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.5 (Yoast SEO v26.5) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>The inside story of how Lykos\u2019 MDMA research went awry<\/title>\n<meta name=\"description\" content=\"The psychedelics company oversaw a pattern of lapses during its clinical trials, according to former employees who spoke with STAT.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.statnews.com\/2024\/06\/09\/mdma-lykos-maps-psychedelics\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The inside story of how Lykos\u2019 MDMA research went awry\" \/>\n<meta property=\"og:description\" content=\"There was mounting excitement about the FDA&#039;s review of Lykos&#039; MDMA-assisted therapy. But former employees said the company committed a series of lapses.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.statnews.com\/2024\/06\/09\/mdma-lykos-maps-psychedelics\/\" \/>\n<meta property=\"og:site_name\" content=\"STAT\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/statnews\/\" \/>\n<meta property=\"article:published_time\" content=\"2024-06-09T12:00:10+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-06-10T14:33:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2024\/06\/ecstacy-04-1024x576.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1024\" \/>\n\t<meta property=\"og:image:height\" content=\"576\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Olivia Goldhill\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@OliviaGoldhill\" 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