The Top Psychedelic Stories of 2023

As we close out the year, let’s take a look back at some of the more important milestones in the psychedelic medicine space. From legalization to clinical trials, the psychedelic sector continued to make steady progress on all fronts.

Here are some of the top psychedelic stories of 2023.

 

 

Australia Legalization

Early in 2023, we received big breaking news on the legalization front as Australia rescheduled certain psychedelics for therapeutic use.

Australia became the first nation to specifically legalize psychedelics, as the nation’s Therapeutic Goods Administration (TGA) will permit the prescribing of MDMA for the treatment of PTSD and psilocybin for treatment-resistant depression.

The roll-out has been slow and there are still many hoops to jump through and problems to solve regarding supply and costs, but a major nation rescheduling psychedelics could have positive repercussions across the entire sector and wider culture.

See clips from Microdose’s virtual conference on Australia’s new psychedelic reforms 

 

Government Support for Psychedelics

Conservative Republican politicians standing outside of Congress, advocating for the legal use of psychedelic medicine. The times are definitely changing, and so is public sentiment around psychedelics.

This summer, Republican lawmakers and former military veterans spoke to the public about the benefits of psychedelic medicine and the urgent need to give soldiers access to these therapies. Rep. Dan Crenshaw (R-TX), himself a wounded military veteran, has been pushing for access to psychedelics, having witnessed first-hand how it’s helped fellow service members. Crenshaw is leading a piece of legislation called the “Douglas ‘Mike’ Day Psychedelic Therapy to Save Lives Act of 2023,” named after a Navy SEAL who died this year.

And recently, a bipartisan group of congressional lawmakers from both the House and the Senate have agreed to add funding for studies of psychedelic therapies into a major defense bill. The 2024 National Defense Authorization Act (NDAA) passed and was signed into law, including the provision for psychedelics research and access to therapies for veterans in need.

The bill’s psychedelic sections require the Department of Defense (DOD) to facilitate access for military veterans to clinical trials for the treatment of PTSD or traumatic brain injury. The provisions allow for participating in studies using psilocybin, MDMA, ibogaine and 5-MeO-DMT (and “qualified plant-based alternative therapies”).

 

I’m live now unveiling the Douglas ‘Mike’ Day Psychedelic Therapy To Save Lives Act: https://t.co/LxuJeHAOoA pic.twitter.com/qpkKuTkKE5

— Rep. Dan Crenshaw (@RepDanCrenshaw) June 14, 2023

 

MindMed’s Phase 2b Trial Using LSD for Anxiety

As the year came to an end, MindMed announced positive topline results from its Phase 2b trial of MM-120 in Generalized Anxiety Disorder. While this news didn’t make huge waves, it was an important reminder of the slow and steady progress of the industry.

MM-120 (MindMed’s form of LSD) at 100 µg demonstrated a clinically and statistically significant HAM-A reduction of 21.3 points, representing a 7.6-point improvement over placebo. The trial met its primary endpoint, with 50% clinical remission rate in the 100 µg dose group at Week 4. An impressive result that adds support for LSD’s potential to treat anxiety.

The company plans to hold an End-of-Phase 2 meeting with the FDA and initiate a Phase 3 clinical program in the second half of 2024. If MindMed can advance into Phase 3 with FDA approval, it will go a long way in helping a mental health condition that affects millions around the world.

 

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A post shared by Microdose Psychedelic Insights (@microdosehq)

 

 

Cybin’s Phase 2 Trials Using Novel Psilocybin for Depression

Cybin’s recent Phase 2 results added additional support for psychedelics being a potentially revolutionary treatment for mental health conditions. Cybin’s Phase 2 trial was examining its novel CYB003 psilocybin compound, engineered for better attributes like shorter trip time.

The results were potentially groundbreaking, as the Phase 2 study of CYB003 in Major Depressive Disorder showed 79% of patients in remission after two 12mg doses.

“CYB003 achieved the primary efficacy endpoint in this study and showed rapid and statistically significant improvements in depression symptoms after a single dose, with a clear incremental benefit of a second dose, resulting in 4 out of 5 patients in remission from their depression at 6 weeks,” said Doug Drysdale, Chief Executive Officer of Cybin.

“This is an impressive finding and follows on from the unprecedented interim results we announced earlier this month. Importantly, the strength of the data supports progression to a Phase 3 study of CYB003 for the treatment of MDD.”

 

MAPS Files New Drug Application With FDA

The psychedelic medicine space moved that much closer to the first psychedelic therapy being approved by the FDA, as MAPS PBC announced the submission of a New Drug Application to the FDA for MDMA-assisted therapy for PTSD,

The historic filing marks the first New Drug Application submission for any psychedelic-assisted therapy:

• Submission represents 30 plus years of clinical research into potential use of MDMA-assisted therapy for PTSD
• NDA includes two Phase 3 trials (MAPP1 and MAPP2) that both met primary and secondary endpoints

With Breakthrough Therapy designation given to MDMA in 2017, MAPS PBC has requested the FDA grant Priority Review of the NDA. The FDA has 60 days to determine whether the NDA will be accepted for review and whether it will be a priority or standard review. If approved by the FDA, the U.S. Drug Enforcement Agency would be required to reschedule MDMA making it available for prescription medical use.

 

For more like this, check out 2022 Review: 3 Trials Pushing Boundaries of Psychedelic Medicine

The post The Top Psychedelic Stories of 2023 appeared first on Microdose.

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