Drug Topics June 7, 2024
Check out important updates from the FDA for the week of June 3.
FDA Advisory Panel Votes Against MDMA-Assisted Therapy for PTSD
An independent FDA advisory panel voted against the use of midomafetamine (MDMA)-assisted therapy to treat post-traumatic stress disorder (PTSD) during a meeting held Tuesday. The Psychopharmacologic Drugs Advisory Committee, which met to discuss the new drug application (NDA) from Lykos Therapeutics, voted 9-2 that MDMA-assisted therapy to treat PTSD is not effective and 10-1 that the benefits of the treatment do not outweigh its risks.
Much of the meeting’s discussion centered around 2 phase 3 clinical trials conducted by Lykos: MAPP1 (NCT03537014) and MAPP2 (NCT04077437). Members of the panel raised concerns about the occurrence of functional unblinding in...
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