Pharmaceutical Executive December 13, 2023
MAPS Public Benefit Corporation filed a new drug application for MDMA (midomafetamine capsules) for use with psychological intervention for the treatment of post-traumatic stress disorder.
MAPS Public Benefit Corporation has submitted a new drug application (NDA) to the FDA in what would represent the first approved psychedelic treatment for post-traumatic stress disorder (PTSD). MAPS is seeking approval of MDMA (midomafetamine capsules) for use with psychological intervention comprised of psychotherapy and additional supportive services provided by a qualified healthcare provider for PTSD.1
MAPS was previously granted Breakthrough Therapy Designation by the FDA for MDMA and is seeking a priority review for the NDA submission.
“The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy,...
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