On June 4, 2024, the FDA Psychopharmacologic Drugs Advisory Committee met to discuss the new drug application submitted by Lykos Therapeutics [for-profit public benefit corporation (PBC) initially part of MAPS (Multidisciplinary Association for Psychedelic Studies)] for MDMA in addition to psychotherapy to treat post traumatic stress disorder (PTSD). MDMA, otherwise known as midomafetamine, methylenedioxymethamphetamine, Ecstasy, or Molly is a Schedule I drug that shows great promise for treating otherwise very difficult to treat psychiatric conditions such as severe PTSD. The committee voted overwhelmingly against the effectiveness of MDMA for PTSD and voted that the benefits of this treatment do not outweigh the risks. In this episode, I unpack this decision, through the lens of all my potential biases as an emergency physician and toxicologist who also believes in the potential of psychedelic assisted psychotherapy. I'll be talking more about this topic in upcoming episodes, especially since the committee's decision is non-binding and the final FDA decision comes in August.
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Music courtesy of Zach Effron, MD
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