Federal health advisers are considering the first request to approve the mind-altering club drug MDMA as a treatment for PTSD. Advisers to the Food and Drug Administration are scheduled to vote on the drug's safety and effectiveness Tuesday afternoon. It potentially sets the stage for federal approval later this year.
FILE - In this photo made with a long exposure, a man is silhouetted against lights reflected in the waters off Cape Neddick in Maine on Dec. 11, 2017. Federal health advisers are considering the first request to approve the mind-altering club drug MDMA as a treatment for PTSD. The advisers to the Food and Drug Administration are scheduled to vote on the drug’s safety and effectiveness Tuesday, June 4, 2024, potentially setting the stage for federal approval later this year.
Because MDMA causes intense psychological experiences, almost all patients in two key studies of the drug were able to guess whether they had received the MDMA or a dummy pill. That’s the opposite of the objectivity usually required for high-quality drug research, in which patients can’t tell whether they’ve received the drug being tested.
FDA regulators also have concerns about the drug’s safety risks, including whether patients may injure themselves if they are still impaired by the drug’s effects, which can last eight hours or more. MDMA is also associated with increased blood pressure.
Anxiety U.S. Food And Drug Administration Mental Health Psychotherapy Post-Traumatic Stress Disorder W Health
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