Flawed, scandalous trials tank FDA skilled assist for MDMA remedy

After a remarkably sensational regulatory drug assessment, advisers for the Meals and Drug Administration on Tuesday voted overwhelmingly in opposition to approving midomafetamine (MDMA, aka ecstasy or molly) as a part of remedy for post-traumatic stress dysfunction.

In a response to the query, “Do the accessible information present that the drug is efficient in sufferers with posttraumatic stress dysfunction?” advisers voted 9 “no” to 2 “sure” in opposition to MDMA.

In response to the second query, “Do the advantages of midomafetamine with FDA’s proposed danger analysis and mitigation technique (REMS) outweigh its dangers for the remedy of sufferers with PTSD?” the advisers voted 10 “no” to 1 “sure” in opposition to MDMA. The one skilled who voted “sure” stated afterward that his confidence in that vote was low.

The votes come after a full-day assembly through which the unbiased skilled advisers heard detailed critiques of scientific trial information from the corporate that proposed the remedy—Lykos, previously MAPS—in addition to inside FDA critiques.

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