Flawed, scandalous trials tank FDA expert support for MDMA therapy

Enlarge / MDMA pills up close. (credit: Getty | Universal History Archive)

After a remarkably sensational regulatory drug review, advisors for the Food and Drug Administration on Tuesday voted overwhelmingly against approving midomafetamine (MDMA, aka ecstasy or molly) as part of therapy for post-traumatic stress disorder.

In a response to the question, "Do the available data show that the drug is effective in patients with posttraumatic stress disorder?" advisors voted 9 "no" to 2 "yes" against MDMA

The votes come after a full-day meeting in which the independent expert advisors heard detailed reviews of clinical trial data from the company that proposed the therapy—Lykos, formerly MAPS—as well as internal FDA reviews.