This marks a significant moment in the widespread acceptance of using psychedelics for therapeutic use.
The Multidisciplinary Association for Psychedelic Studies (MAPS) has submitted its application to the FDA for the approval of MDMA-assisted therapy for patients with PTSD.
This marks a significant moment in psychedelic research for therapeutic use following 30 years of clinical research. The anticipation of MDMA's regulatory approval reflects a growing understanding of its therapeutic benefits, challenging long-held stigmas associated with psychedelic drugs.
MAPS’ MDMA application could see FDA approval by August with priority review. The organization’s goal is to explore the therapeutic potential of MDMA in areas where effective treatments are currently limited, with a particular emphasis on disorders that disproportionately affect women.
Founded in 1986, MAPS initiated its first clinical trial involving MDMA for PTSD in 2004. The MAPS Public Benefit Organization, focused on FDA approval, was launched in 2014.
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