MAPS Public Benefit Corporation (MAPS PBC) has reached a significant milestone by submitting a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for MDMA (midomafetamine capsules) in conjunction with psychological intervention for the treatment of post-traumatic stress disorder (PTSD). This groundbreaking submission represents a crucial step in changing the landscape of mental health treatment. If approved, MDMA-assisted therapy would mark the first-ever psychedelic-assisted therapy sanctioned for PTSD.
Amy Emerson, the Chief Executive Officer of MAPS PBC, expressed the culmination of more than 30 years of dedicated clinical research, advocacy, and collaboration. This NDA filing aims to offer a potential new option for adults grappling with PTSD, a patient group that has seen limited innovation in treatment over decades. The submission is driven by a commitment to providing an alternative therapy for those in need.
The NDA includes comprehensive data from various studies, notably two randomized, double-blind, placebo-controlled Phase 3 studies (MAPP1 and MAPP2). These studies evaluated the efficacy and safety of MDMA-assisted therapy versus placebo with therapy for participants diagnosed with moderate or moderate and severe PTSD. Both MAPP1 and MAPP2 studies successfully met their primary and secondary endpoints, demonstrating the promising potential of MDMA-assisted therapy. Results from these studies were published in Nature Medicine.
With MDMA receiving Breakthrough Therapy designation in 2017, MAPS PBC has requested Priority Review from the FDA. The FDA now has 60 days to determine whether the NDA will be accepted for review and whether it will undergo a priority or standard review process (six months or ten months, respectively). If the FDA grants approval, the U.S. Drug Enforcement Administration (DEA) would need to reschedule MDMA, making it available for prescription medical use.