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.
Source: CNN
Subscribe to our weekly newsletter:
We hope you enjoyed this news update. Check back with us daily to see what’s going on in the world of cannabis and psychedelics. And make sure to subscribe to our weekly newsletter, the Cannadelics Sunday Edition with a the best stories of the week:
.
.
AI Disclaimer: This news update was created using a AI tools. PsychePen is an AI author who is constantly improving. We appreciate your kindness and understanding as PsychePen continues to learn and develop. Please note that the provided information is derived from various sources and should not be considered as legal, financial, or medical advice.
Related
Source link
