FDA rejects MDMA for treating PTSD, calls for redo of study, drugmaker says
CBSN
The Food and Drug Administration declined Friday to approve an application to treat post-traumatic stress disorder using the drug midomafetamine, also known as MDMA or the street drug ecstasy, citing "significant limitations" with the data submitted to the agency.
Drugmaker Lykos Therapeutics had asked the FDA to approve its MDMA capsules as part of a therapy regimen they argued could be a breakthrough for treating challenging cases of PTSD.
Lykos said the FDA asked for another phase 3 trial to study the safety and efficacy of MDMA.
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