(Reuters) -The U.S. health regulator’s staff reviewers on Friday raised concerns related to interpretation of results from trials for Lykos Therapeutics psychedelic drug MDMA to treat post-traumatic stress disorder.
The FDA staff, in the briefing documents, said several factors make it challenging to interpret data from the trials, including that Lykos’ study staff and enrolled patients were likely aware of whether a participant was assigned MDMA or placebo.
This comes ahead of a meeting of a panel of outside advisers to the U.S. Food and Drug Administration on Tuesday to review for the first time a form of MDMA.
The agency has so far never approved the therapeutic use of the mind-altering drug, commonly called ecstasy or molly.
The FDA will make its final decision on the drug after the advisers’ recommendations, which the agency is not obligated to follow but it usually does.
If approved, it would mark a watershed moment for psychedelic researchers who say drugs like MDMA can treat mental health disorders and have therapeutic applications beyond their illicit use.
(Reporting by Sriparna Roy and Pratik Jain in Bengaluru; Editing by Shilpi Majumdar)
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