Federal health advisers are considering the first request to approve the mind-altering club drug MDMA as a treatment for PTSD.
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. 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. Recommended Videos
MDMA, sometimes called ecstasy or molly, would become the first illegal psychedelic, if approved, to make the leap to mainstream medicine. The drug is the first in a— including LSD and psilocybin — that are expected to come before the FDA in the next few years as part of renewed research and interest into their potential to address hard-to-treat conditions like depression, addiction and anxiety.
“This makes it hard to know how much of the treatment effect is a true benefit and how much is due to expectation bias,” Farchione said. Because of those risks, the FDA has proposed strict limits on how and where MDMA could be used if approved. Only specially certified doctors and therapists would be able to prescribe and administer the drug. Patients would have to be registered and tracked over time. Health professionals also would need to be available to measure patients' vital signs while taking the drug.
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