FDA Panel Votes Against MDMA-Assisted Therapy for PTSD
The panel voted 9"np" to 2 "yes" on whether the available data show that MDMA is effective in patients with PTSD.
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The panel voted 9"np" to 2 "yes" on whether the available data show that MDMA is effective in patients with PTSD.
The panelists expressed concerns about clinical trial data and concluded that the benefits do not outweigh the risks.
Lykos Therapeutics' new drug application for MDMA plus psychiatric intervention for adults with PTSD will be the first reviewed by an FDA committee for such a therapy.
The FDA has accepted for Priority Review the NDA for midomafetamine capsules (MDMA) in combination with psychological intervention for the treatment of PTSD.
The investigational therapy combines MDMA, a psychoactive drug, with psychological interventions that include psychotherapy, talk therapy and other supportive services.