FDA advisers cited a variety of concerns with the trials submitted by Lykos Therapeutics as part of the application.
Potential approval of MDMA to treat post-traumatic stress disorder hit a major hurdle Tuesday, as a panel of the Food and Drug Administration's outside advisers voted against the treatment.The committee voted nine against, two in favor, on the question of whether there was enough data to show the drug was effective in treating PTSD. The drug, which doctors call midomafetamine, is sold illegally as the street drug ecstasy.
Some members raised concerns about the ways the studies were designed and their results, along with the drugmaker's failure to collect data requested by the FDA.
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