‘Party Drug’ MDMA Goes to Panel for PTSD

Federal Register notice: FDA is announcing a 6/4 Psychopharmacologic Drugs Advisory Committee meeting to discuss a Lykos Therapeutics NDA for midomafetamine (MDMA) capsules for a proposed indication of treating post-traumatic stress disorder. The panel will be asked to discuss the overall benefit-risk profile of MDMA, including the potential public health impact. MDMA has historically been known as the party drug Ecstasy or Molly. The submission is based on data from two randomized, double-blind, placebo-controlled Phase 3 studies (MAPP1 and MAPP2) evaluating the efficacy and safety of MDMA used in combination with psychological intervention versus placebo with therapy in participants diagnosed with severe or moderate to severe PTSD, according to the company. Both MAPP1 and MAPP2 studies met their primary and secondary endpoints and were recently published in Nature Medicine. The agency has set an 8/11 user fee review action target date. To view the notice, click here.