Summary: The US Food and Drug Administration (FDA) has been requested to review MDMA, also known as midomafetamine, as a potential treatment for post-traumatic stress disorder (PTSD). MDMA, the active ingredient in street drugs like ecstasy and molly, is being considered for its therapeutic benefits in combination with regular PTSD therapy.
MDMA for PTSD Therapy: FDA’s Potential Approval and Rescheduling
MDMA, a psychedelic drug known for producing experiences of emotional communion and openness, is being evaluated for its potential in PTSD therapy. The MAPS Public Benefit Corporation, which has been studying MDMA in combination with therapy for PTSD, has filed a new application with the FDA. The FDA now has 60 days to decide whether to accept the new drug application (NDA) for review and whether to fast-track the approval process.
In 2017, the FDA granted MDMA-assisted therapy a breakthrough therapy designation, recognizing its potential to substantially improve over existing therapies for serious conditions. Clinical trials involving MDMA have shown significant reductions in PTSD symptoms and impairment compared to a placebo. MAPS has completed six late-stage clinical trials testing MDMA for PTSD.
Amy Emerson, CEO of MAPS, emphasized the importance of this development, stating that the filing of the NDA represents over 30 years of clinical research and advocacy. The goal is to bring a new treatment option to adults living with PTSD, a patient group that has seen little innovation in decades.
Current treatments for PTSD include antidepressants and specialized forms of cognitive behavioral therapy. While these treatments can be beneficial, they are only modestly effective for some individuals. MDMA-assisted therapy could offer an alternative for those who do not respond to existing options.
If the FDA approves MDMA for treating PTSD, it would require rescheduling the drug. Currently, MDMA is classified as a Schedule I drug under the Controlled Substances Act, indicating no accepted medical use.
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