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
In response to the second question, “Do the benefits of midomafetamine with FDA’s proposed risk evaluation and mitigation strategy (REMS) outweigh its risks for the treatment of patients with PTSD?” the advisors voted 10 “no” to 1 “yes” against MDMA. The one expert who voted “yes” said afterward that his confidence in that vote was low.
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.
