First Time MDMA Filed for FDA Approval, Questions About Repercussions Unanswered

The new drug application (NDA) included results from two randomized, double-blind, placebo-controlled studies, both of which were published in Nature.

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The first-ever application for midomafetamine, commonly known as MDMA, to be approved as a new therapeutic drug was submitted to the U.S. Food and Drug Administration (FDA) on Tuesday.

If approved, it would be the first psychedelic-assisted therapy, but this raises concerns for some experts.