An advisory panel for the Food and Drug Administration voted Tuesday against the approval of MDMA, also known as ecstacy, for the treatment of post-traumatic stress disorder, according to multiple outlets, marking a possible loss for the first-of-its-kind proposal.
The FDA will make a final vote on the proposal in August. (Photo by Sarah Silbiger/Getty Images)
Nine of the panel’s 11 members voted against recommending the use of MDMA as a treatment for PTSD, citing flawed trials and research conduct, the CNN and NBC reported.
The FDA will make a final decision on the proposal on Aug. 11 and does not have to follow the panel’s recommendations—though it usually does, according to Axios.
Panelists specifically scrutinized missing follow-up data on patient outcomes, a lack of patient diversity and potentially skewed results, the Associated Press reported.
MDMA, a stimulant and psychedelic, is designated as a Schedule I drug with high potential for abuse and has no accepted medical use in the U.S.
If the FDA were to approve the proposal, MDMA would become the first Schedule I psychadelic drug approved for medical use and the first new treatment for PTSD in more than 20 years.
This is a developing story. Check back for updates.