{"title":"FDA公开发布MDMA拒绝信;MAPS誓言要继续推进","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":"{\"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}","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}
FDA publicly releases MDMA rejection letter; MAPS vows to press forward
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.