This Week in Psychedelics

MAPS submits application for first-ever FDA approved psychedelic-assisted therapy for PTSD; MindMed announces results for its drug MM-120.

December 15, 2023

This Week...

MAPS Public Benefit Corporation submitted a new drug application to the U.S. Food and Drug Administration for MDMA (midomafetamine) capsules used in combination with psychological intervention, which includes psychotherapy, aka talk therapy, and other supportive services provided by a qualified healthcare provider.

This investigational MDMA-assisted therapy is in development for individuals with post-traumatic stress disorder and if approved, would be the first psychedelic-assisted therapy approved for PTSD. This is a very big deal. Check it out:

MindMed announced positive topline results from its Phase 2b clinical trial of its MM-120 (lysergide d-tartrate), which is designed to treat generalized anxiety disorder.

The trial met its primary endpoint, with MM-120 demonstrating statistically significant and clinically meaningful dose-dependent improvements on the Hamilton Anxiety rating scale compared to placebo at Week 4. MM-120 was administered as a single-dose in a monitored clinical setting with no additional therapeutic intervention. Here’s more:

Lawmakers in Provincetown, Massachusetts, voted to adopt a resolution in support of decriminalizing the use, possession, and noncommercial sharing of psychedelic plants and fungi. It’s the seventh municipality in the state to deprioritize arrests for entheogens.

The statement also calls on the county district attorney to cease prosecutions for psychedelics-related activity as well as for simple possession of all drugs. Further, it urges state lawmakers to amend a pending proposal that would legalize psychedelics in all of Massachusetts and could end up on the 2024 ballot. Check it out:

Did You Know?

Did you know that the U.S. Congress just sent President Biden a defense bill that includes the funding of studies into psychedelics therapy for active duty military?

The adopted psychedelics section would require the Department of Defense (DOD) to establish a process by which service members with post-traumatic stress disorder or traumatic brain injury could participate in clinical trials involving psilocybin, MDMA, ibogaine and 5-MeO-DMT. The list of covered psychedelics was also expanded to broadly include “qualified plant-based alternative therapies."

The DOD would need to facilitate that process within 180 days of enactment, and could partner with eligible federal or state government agencies, as well as academic institutions to carry out the clinical trials, with $10 million in funding.