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Following the vote of the US Food and Drug Administration Psychopharmacologic Drugs Advisory Committee, Lykos has released a statement on MDMA-assisted therapy.
A pharmaceutical version of MDMA, also known as midomafetamine, could become a new treatment for PTSD ... as advisers for the U.S. Food and Drug Administration are considering whether to recommend it for approval.
An FDA advisory panel has recommended that the agency not approve the use of MDMA-assisted therapy as a treatment for PTSD.
The panel voted 9"np" to 2 "yes" on whether the available data show that MDMA is effective in patients with PTSD.
The panel's recommendation, based on several concerns about two clinical trials, is a serious setback for a promising PTSD treatment.