By Matthew Perrone | Associated Press WASHINGTON — Federal health advisers are weighing the first-of-a-kind approval of MDMA, the mind-altering club drug, as a treatment for PTSD — part of a decade…
File photo: The Food and Drug Administration convened a panel of outside experts Tuesday to review the latest research on the drug, which appears to show it can help relieve post-traumatic stress disorder when combined with talk therapy.WASHINGTON — Federal health advisers are weighing the first-of-a-kind approval of MDMA, the mind-altering club drug, as a treatment for PTSD — part of a decadeslong effort by psychedelic advocates to win medical acceptance for the drug’s purported benefits.
The FDA panel will vote later Tuesday on whether to recommend the drug’s use for PTSD, which could set the stage for federal approval later this summer, though the FDA isn’t required to follow the group’s recommendations. 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. “It’s clear that MDMA-assisted therapy would be a welcome addition to the currently available options,” said Dr. Kelley O’Donnell, a New York University psychiatrist who helped conduct the MDMA studies. “I’ve seen firsthand how this treatment can be lifesaving for some.”Illegal ecstasy takes step toward becoming legal drug for PTSD
MDMA acts on two feel-good brain chemicals that are thought to improve talk therapy: serotonin and dopamine. Experts believe the drug helps patients confront past traumas by reducing fear and enhancing their connection and trust with therapists.
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