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A panel of US health experts convened by the Food and Drug Administration on Tuesday overwhelmingly voted against the use ofPTSD, a debilitating mental health condition that develops after a person experiences or is threatened by traumatic events such as death, combat or sexual assault, affects an estimated five percent of Americans in any given year.
California-based Lykos Therapeutics has based its request for regulatory approval on two clinical studies, each of which enrolled around 100 people, to evaluate MDMA used together with other psychological interventions such as talk therapy, against a "I think this is a really exciting treatment. I'm really encouraged by the results to date," said one of the experts, Paul Holtzheimer of the National Center for PTSD.Not enough side effect data
Reports from recreational use suggest MDMA has harmful impacts on heart and liver health – but the company did not gather enough data in these areas, the FDA said.Then there were troubling allegations of research impropriety linked to the trials that surfaced in a draft report by the nonprofit Institute for Clinical and Economic Review.
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FDA panel rejects first MDMA treatment amid deep concerns about flawed trialsBerkeley Lovelace Jr. is a health and medical reporter for NBC News. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. He previously covered the biotech and pharmaceutical industry with CNBC.
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Panel rejects psychedelic drug MDMA as a PTSD treatment in possible setback for advocatesThe panel of advisers to the Food and Drug Administration voted 10-1 against the overall benefits of MDMA when used to treat post-traumatic stress disorder
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Panel rejects psychedelic drug MDMA as a PTSD treatment in possible setback for advocatesFederal health advisers voted Tuesday against a first-of-a-kind proposal to begin using the mind-altering drug MDMA as a treatment for PTSD,
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Panel rejects psychedelic drug MDMA as PTSD treatment in possible setback for advocatesFederal health advisers voted Tuesday against a first-of-a-kind proposal to begin using the mind-altering drug MDMA as a treatment for PTSD.
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Panel rejects psychedelic drug MDMA as a PTSD treatment in possible setback for advocatesFederal health advisers are rejecting the first-ever proposal to use MDMA as a treatment for PTSD
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Federal health advisory panel rejects psychedelic drug MDMA as a PTSD treatmentA panel of advisers to the FDA voted against the overall benefits of MDMA when used to treat PTSD, citing flawed study data, questionable research conduct and significant drug risks, including the potential for heart problems, injury and abuse.
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