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The FDA Just Rejected a Bid for MDMA to Treat PTSD
The agency has asked drugmaker Lykos Therapeutics to run an additional study on the use of the psychedelic drug in patients with post-traumatic stress disorder, pushing back its next proposal by years.
"The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades," said Lykos CEO Amy Emerson in a company statement. But with the FDA decision, MDMA will remain a federally prohibited substance listed as Schedule I drug, defined as those that have “no currently accepted medical use and a high potential for abuse.” Despite the positive results, advisory committee members cited concerns about the reliability of the clinical trial data, the long-term efficacy of the treatment, and the standardization of the talk therapy given during the MDMA sessions.
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