FDA panel votes against MDMA for PTSD, setting up hurdle to approval
CBSN
Potential approval of MDMA to treat post-traumatic stress disorder hit a major hurdle Tuesday, as a panel of the Food and Drug Administration's outside advisers voted against the treatment.
The committee voted nine against, two in favor, on the question of whether there was enough data to show the drug was effective in treating PTSD. The drug, which doctors call midomafetamine, is sold illegally as the street drug ecstasy.
While the FDA is not required to follow the committee's votes, agency officials often follow the panel's feedback. Sometimes drugmakers end up having to run different studies before they resubmit for the FDA's approval.
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