{"title":"FDA publicly releases MDMA rejection letter; MAPS vows to press forward","authors":"Valerie A. Canady","doi":"10.1002/mhw.34582","DOIUrl":null,"url":null,"abstract":"<p>In a historic move toward transparency, the U.S. Food and Drug Administration (FDA) on Sept. 4 publicly released its Complete Response Letter (CRL) rejecting the approval of midomafetamine (MDMA)-assisted therapy for post-traumatic stress disorder (PTSD). The letter, sent to Lykos Therapeutics in August 2024, outlines concerns about treatment durability, study design and prior MDMA use among participants — issues that critics say were not flagged during earlier protocol discussions.</p>","PeriodicalId":100916,"journal":{"name":"Mental Health Weekly","volume":"35 35","pages":"1-6"},"PeriodicalIF":0.0000,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Mental Health Weekly","FirstCategoryId":"1085","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/mhw.34582","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
In a historic move toward transparency, the U.S. Food and Drug Administration (FDA) on Sept. 4 publicly released its Complete Response Letter (CRL) rejecting the approval of midomafetamine (MDMA)-assisted therapy for post-traumatic stress disorder (PTSD). The letter, sent to Lykos Therapeutics in August 2024, outlines concerns about treatment durability, study design and prior MDMA use among participants — issues that critics say were not flagged during earlier protocol discussions.
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