FDA won't approve psychedelic MDMA for PTSD:
Federal health officials have declined to approve the psychedelic drug MDMA as a therapy for PTSD ...
apnews.com/article/mdma-psychedelic-drug-fda-ptsd-lykos-709b23613031fb11d3dc5228c8476a39
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FDA rejects MDMA therapy for PTSDLykos was notified Friday; the agency is requesting an additional late-stage study.
Key FactsAug 10, 2024 · Reading time: ~45 sec.
Summary created with AI assistance · Source: apnews.com
Summary created with AI assistance · Source: apnews.com
- On August 9, the FDA told Lykos Therapeutics the drug could not be approved based on data submitted to date.
- The agency requested an additional late-stage study, and Lykos said it plans to seek reconsideration.
- Government advisers overwhelmingly opposed MDMA in June after reviewing study data, methods and potential risks.
- FDA staff said the vast majority of patients guessed their treatment; separate allegations of research misconduct also emerged against researchers.
The FDA request for another study is deeply disappointing,— Amy Emerson, CEO of Lykos Therapeutics, said Friday in a statement.
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mental disorder that developed after experiencing or witnessing a terrifying or life-threatening event
agency of the US Department of Health and Human Services
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