MDMA THERAPY FOR PTSD IS “ON TRACK” FOR FDA CONSIDERATION

CCJ Gabriel
MDMA THERAPY FOR PTSD IS “ON TRACK” FOR FDA CONSIDERATION

A peer-reviewed study in Nature has found that MDMA therapy for PTSD reduced symptoms in patients with moderate to severe PTSD. The study's Phase 3 trial findings suggest federal regulators could consider approving MDMA for wider use as soon as next year. The Multidisciplinary Association for Psychedelic Studies (MAPS) sponsored the research, which involved 104 people with PTSD who received either MDMA or a placebo, then paired the experience with talk therapy. The findings suggest MDMA could be a game-changer, as conventional therapies and medications work for only about half of patients. MAPS Public Benefit Corp. will file a new drug application with the FDA later this year, potentially leading to FDA approval in 2024. The study published in Nature Medicine has found that MDMA, a potent treatment option for mental health disorders, does not significantly affect disease severity, risk of hazardous alcohol or substance use disorder, severe adverse childhood experiences, or dissociative subtype. Common issues were similar to previous studies and consistent with the expected effects of MDMA, including mild, transient increases in blood pressure and heart rate. Suicidal ideation was observed in both groups, but MDMA did not increase this risk and no suicidal behavior was observed. The study is not an apples-to-apples comparison between treatment methods, and the complex relationship between SSRI use/history and MDMA-AT treatment efficacy cannot be assumed without a direct comparison. Further study of MDMA with other forms of psychotherapy for PTSD should be explored. The study highlights the urgency of equipping therapists with the skills and knowledge necessary to provide psychedelic therapy. The DEA proposed higher manufacturing quotas for MDMA, LSD, psilocybin, mescaline for research purposes. Australia also legalized MDMA and psilocybin for prescription use in February, ensuring an adequate supply of controlled substances for the US.

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