The FDA expert panel will consider recommending the approval of an MDMA capsule in combination with psychological intervention for PTSD treatment. The drug manufacturer, Lykos Therapeutics, has faced questions about the ethics and validity of clinical trials used to support their application. Critics have raised concerns about bias, lack of blinding in the study design, and ethical lapses. However, supporters, including veteran groups, advocate for the approval of MDMA-AT. If approved, it would be the first psychedelic-based therapeutic for any condition in the US and the first medication for PTSD in 24 years. The FDA is expected to make a decision by August 11.
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Controversy Grows as FDA Panel Prepares to Review MDMA Drug
