MedPath

Midomafetamine

Generic Name
Midomafetamine
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C11H15NO2
CAS Number
42542-10-9
Unique Ingredient Identifier
KE1SEN21RM
Background

An N-substituted amphetamine analog. It is a widely abused drug classified as a hallucinogen and causes marked, long-lasting changes in brain serotonergic systems. It is commonly referred to as MDMA or ecstasy. It is a widely abused drug classified as a hallucinogen and causes marked, long-lasting changes in brain serotonergic systems.

Indication

Clinical trials are now testing the therapeutic potential of MDMA for post-traumatic stress disorder (PTSD) and anxiety associated with terminal cancer. MDMA is one of the four most widely used illicit drugs in the U.S.

Associated Conditions
-
Associated Therapies
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Emyria announces interim clinical trial results for PTSD program

Emyria reports interim clinical results from its MDMA-assisted therapy for PTSD, showing improved outcomes for eight patients with moderate to severe PTSD. The program aims to recruit 70 patients.
drugs.com
·

Recreational Drug Use Triples Odds for Repeat Heart Crises

Recreational drug use triples the risk of repeat heart crises within a year, with MDMA users four times more likely, according to a study by Dr. Raphael Mirailles.
npr.org
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The Promise and Future of Psychedelics Research

Interest in psychedelics for mental health treatments surged, but faced a setback when FDA rejected MDMA for PTSD, citing need for more safety and efficacy research. This decision may push the research community back underground. The episode explores psychedelics' potential and challenges, including MDMA, ketamine for depression, and psilocybin for cluster headaches.
nature.com
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FDA rejects ecstasy as a therapy: what’s next for psychedelics?

The FDA's rejection of MDMA (ecstasy) as a psychiatric treatment has raised questions about the future of psychedelic therapies. Lykos Therapeutics plans to appeal the decision, while researchers ponder the implications for other hallucinogens in clinical trials.
drugs.com
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Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD

Lykos Therapeutics received a complete response letter from the FDA for midomafetamine capsules for PTSD, requesting an additional Phase 3 trial. The company plans to meet with the FDA to discuss resubmission and address concerns raised during the Advisory Committee meeting.
apnews.com
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FDA rejects psychedelic MDMA as treatment for PTSD, calling for additional study

FDA declined approval for MDMA as PTSD therapy, citing insufficient data and safety concerns, despite advocacy from veterans and mental health groups. Lykos Therapeutics plans to request reconsideration. This decision impacts the broader push for psychedelic treatments, with ongoing research into substances like psilocybin for mental health conditions.
forbes.com
·

Why FDA Panel Rejected MDMA Therapy—And What’s Next For Psychedelic Medicine

An FDA advisory panel voted against approving MDMA-assisted therapy for PTSD, questioning the credibility of research and safety in trials. Despite MDMA's therapeutic potential and prior FDA acknowledgment, concerns over data validity, trial diversity, and adverse effects were raised. The decision casts doubt on the future of psychedelic-assisted psychotherapy, emphasizing the need for rigorous trials and ethical practices.
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